Revolutionizing Diabetes Care: Key Insights from the Roche Diabetes Care Network Meeting and the Future of Diabetes Programs

The 12th Roche Diabetes Care Network Meeting in Copenhagen convened a global panel of experts in diabetes and diabetes technology to foster knowledge exchange, spark collaborations, and stimulate research aimed at enhancing the lives of individuals with diabetes. This pivotal meeting underscored the critical areas shaping the future of diabetes care, including the expanding role of telemedicine and mobile health, the complexities of behavior change, the imperative of patient-centered care, and holistic strategies for managing the multifaceted metabolic disturbances associated with diabetes. The 2019 meeting delivered a comprehensive scientific agenda, highlighted by four insightful keynote addresses, all pointing towards advancements that resonate with the core principles of a robust Roche Diabetes Care Program.

News from the World of Diabetes: Evolving Landscapes and Emerging Challenges

Satish Garg from the University of Colorado Denver provided an opening lecture that painted a vivid picture of the swiftly changing healthcare and diabetes market. An aging global population, particularly in the United States where approximately 25% of insulin-treated diabetes patients are over 65, presents escalating healthcare demands. The persistent challenge of suboptimal diabetes management in a significant portion of patients is fueling technological and scientific innovation, prompting the development of novel metrics for diabetes assessment and monitoring. These advancements are also urging regulatory bodies to re-evaluate their criteria for safety and efficacy assessments. Moreover, affordability and accessibility of healthcare products and services remain paramount concerns as we move forward, factors that any effective Roche diabetes care program must address.

Challenges of Diabetes Prevalence: A Global Perspective

The staggering rise in diabetes prevalence, now affecting over 435 million individuals globally—a nearly fourfold increase in four decades—underscores the urgency of innovative solutions. In the United States, diabetes impacts roughly 14% of the population, encompassing both diagnosed and undiagnosed cases.1 The global estimate of 200 million diabetes patients requiring insulin, with approximately 90% having type 2 diabetes (T2D), further emphasizes the scale of the challenge. It’s also crucial to recognize the diagnostic nuances, with about 25% of type 1 diabetes (T1D) patients remaining C-peptide positive and a significant 10%–20% of T2D diagnoses potentially being misdiagnosed glutamic acid decarboxylase autoantibody-positive individuals.

Addressing the healthcare needs of insulin-dependent diabetes patients presents ongoing challenges for healthcare systems, payers, and society at large. A significant proportion of diabetes patients are not achieving their glycemic targets.2,3 The dwindling number of endocrinologists means more patients are under the care of primary care physicians, many of whom may lack specialized expertise in insulin management. While technologies like insulin pumps and closed-loop systems have proven efficacy in improving diabetes control, their adoption remains slow due to accessibility and affordability barriers, highlighting the necessity for programs like a comprehensive Roche diabetes care program to bridge these gaps.

To effectively manage this expanding healthcare landscape, new care paradigms are essential. Telemedicine, coaching, and digital decision support tools, alongside affordable medications and technologies, are crucial for streamlining care delivery and improving health outcomes for a wider population. Without these advancements, many will be left behind in the evolving world of diabetes management.

Going Beyond Glycated Hemoglobin: Embracing Time in Range

While glycated hemoglobin (HbA1c) has long been the gold standard for assessing glycemic control over 2–3 months, its limitations are becoming increasingly apparent. Each HbA1c level represents a broad mean glucose range, potentially leading to under- or overtreatment. Furthermore, HbA1c fails to capture the nuances of inter- and intraday glucose fluctuations, limiting its utility in daily diabetes management. This is where the principles of a Roche diabetes care program, focused on holistic and real-time data, become particularly relevant.

Satish Garg, MD, delivering the opening keynote lecture on “News from the World of Diabetes.”

An emerging concept gaining traction is the use of “time in ranges”—within, above, and below target glucose levels—for a more dynamic glycemic assessment. A recent consensus panel has provided guidance on utilizing these metrics with continuous glucose monitoring (CGM) data, along with recommendations for standardizing glucose data reporting using the Ambulatory Glucose Profile (AGP).4 Beyond time in range percentages, the AGP introduces the glucose management indicator, a novel metric that closely correlates with calculated HbA1c but utilizes data from a much shorter 2-week period, offering a more timely and actionable insight into glycemic control, a key feature that could be integrated into a Roche diabetes care program to enhance patient monitoring and personalized adjustments.

Adjunctive Therapy for T1D: Expanding Treatment Horizons

Over the years, researchers have explored various adjunctive therapies for T1D. Pramlintide, while FDA-approved, faced challenges due to gastrointestinal side effects and increased hypoglycemia. However, sodium/glucose cotransporter (SGLT) inhibitors—empagliflozin, dapagliflozin (SGLT-2), and sotagliflozin (SGLT-1&2)—emerge as promising adjunctive treatments. These medications primarily function by preventing glucose reabsorption in the kidneys.

Initially approved for T2D, these agents have been extensively evaluated in T1D through programs like Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes (DEPICT),5,6 inTandem,7–9 and Empagliflozin as Adjunctive to Insulin thErapy (EASE).10 These studies demonstrated that SGLT-2 and SGLT-1&2 inhibitors can improve glycemic control (HbA1c reduction and increased time in range) and offer significant cardiometabolic and potential long-term renal benefits in individuals with T1D, without a marked increase in hypoglycemia. However, an elevated risk of diabetic ketoacidosis (DKA), sometimes presenting as euglycemic DKA (euDKA) with near-normal glucose levels, was observed.

To mitigate DKA risk, an international consensus panel has published guidelines.11 This highlights the importance of careful patient selection and education when considering adjunctive SGLT inhibitor therapy in T1D, aspects that a responsible Roche diabetes care program would prioritize.

Emerging Health Problems: NAFLD and NASH

The global rise of nonalcoholic fatty liver disease (NAFLD) to a 25% prevalence and nonalcoholic steatohepatitis (NASH), a more severe form of NAFLD with hepatitis, estimated at 6.5% worldwide and 12% in the United States, represents another significant health challenge. NASH is closely linked to metabolic comorbidities of diabetes, including obesity, hypertension, and dyslipidemia. While various diabetes medications are being investigated for their potential in treating these conditions, a recent report highlighted the effectiveness of Revita Duodenal Mucosal Resurfacing, an innovative endoscopic procedure using heat to ablate the duodenal lining, achieving a 36% reduction in liver fat. This interdisciplinary approach to managing diabetes and its related complications underscores the comprehensive scope needed in modern diabetes care, aligning with the principles of a forward-thinking Roche diabetes care program.

Summary of Emerging Diabetes Trends

The healthcare landscape is rapidly transforming diabetes management. The increasing prevalence of diabetes and the growing population of insulin-dependent patients necessitate metrics beyond HbA1c for more accurate glycemic assessment and improved outcomes. Prioritizing the development of adjunctive therapies that aid in weight management and reduce hypoglycemia risk remains crucial in ongoing and future research. These evolving trends and research priorities are central to the development and refinement of programs like the Roche diabetes care program, ensuring they remain at the forefront of diabetes care innovation.

Diabetes Is More Than Elevated Glycated Hemoglobin: Expanding the Focus for Long-Term Outcomes

Stephan Jacob from Gemeinschaftspraxis Prof. Dr. Stephan Jacob und Dr. Frohmut Jacob Diabetes & Endocrinology emphasized in his keynote lecture that managing diabetes effectively requires moving beyond a singular focus on glycated hemoglobin. He highlighted the need to consider a broader spectrum of factors to achieve meaningful long-term outcomes for patients.

Background: The Complexity of Type 2 Diabetes

The escalating prevalence of T2D and its associated complications pose a significant threat to healthcare systems globally. Individuals with T2D face a higher risk of complications compared to those with T1D, with a reduced life expectancy of 6 years, and a further reduction to 12 years if a myocardial infarction occurs. Traditionally, T2D management has primarily centered on glucose control. However, it’s crucial to acknowledge that over 80% of T2D patients present with metabolic syndrome, a condition affecting multiple organ systems. This multifaceted nature of T2D necessitates a comprehensive approach, reflecting the philosophy of a modern Roche diabetes care program.

Impact of Glycemic Control: Rethinking HbA1c as the Sole Measure

HbA1c has been the most commonly used endpoint to evaluate the relationship between glycemic control and diabetes complications. While clear associations exist between HbA1c levels and complications, most intervention studies aimed at lowering HbA1c have failed to demonstrate a reduction in morbidity and mortality. Although some studies have shown HbA1c improvements with intensive interventions compared to usual care,12–15 often the “usual care” in these studies was suboptimal, as exemplified by the Veterans Administration Diabetes Trial (VADT).15 The fact that intensive HbA1c lowering interventions do not consistently translate to reduced all-cause mortality in the short term raises questions about whether the benefits of aggressive glycemic control always outweigh the added burden on patients.

Is HbA1c the Correct Measure of Diabetes Control?: Considering Broader Metrics

Several factors may explain the limited success of intensive therapies in reducing mortality, including clinical inertia. However, evidence suggests that HbA1c itself may be an inadequate clinical target, particularly given the side effects of intensive management, such as weight gain and hypoglycemia, which are known cardiovascular (CV) risk factors. The LEADER study, for instance, demonstrated a strong link between severe hypoglycemia and all-cause mortality.16 Furthermore, HbA1c only reflects average glucose levels over the past 3 months, providing no insight into intra- and interday glucose excursions, which are increasingly recognized as important factors in overall glycemic health. This limitation underscores the need for more dynamic and patient-centric metrics, a core consideration in the design of a Roche diabetes care program.

Lack of Safety Studies for CV Risk: The Importance of Comprehensive Evaluation

Historically, many early diabetes medications were not rigorously evaluated for CV safety in randomized controlled trials (RCTs), with acarbose and glargine being notable exceptions. However, newer medications, including thiazolidinediones, dipeptidyl peptidase-4 (DPP-4) inhibitors, SGLT inhibitors (SGLT-2, SGLT-1&2), and glucagon-like peptide (GLP-1) agonists, have undergone extensive CV risk assessments. A recent study by O’Brien et al. found that these newer medications were associated with a significantly lower risk of a first major CV event compared to sulfonylurea or glargine treatment in T2D patients already on metformin.17 The EMPA-REG study further highlighted the CV benefits of empagliflozin (SGLT-2 inhibitor) in T2D patients, with significant reductions in CV events.18 Other SGLT-1/SGLT-1&2 studies have also shown reduced risks of renal disease. These findings emphasize the importance of considering CV and renal outcomes in diabetes management, a holistic perspective that should be embedded in any comprehensive Roche diabetes care program.

Stephan Jacob, MD, arguing for the need to move beyond HbA1c as the primary marker of diabetes control.

Multifactorial Approach to Diabetes Management: Addressing the Metabolic Syndrome

While glucose control remains a vital aspect of diabetes therapy, a multifactorial approach is essential to effectively reduce diabetes complications. The STENO-2 trial demonstrated that individuals who achieved good control of glucose, blood pressure, and lipids experienced sustained benefits in reducing vascular complications and all-cause mortality over a 21.2-year follow-up.19 A population-based study examining five clinical measures—glucose, blood pressure, lipids, albuminuria, and smoking—found that T2D patients well-controlled across all these measures had the same CV disease and mortality risk as individuals without diabetes.20 These studies suggest that for individuals with elevated HbA1c and high CV risk, GLP-1 receptor agonists or SGLT-2/SGLT-1&2 inhibitors should be considered for treatment intensification. This emphasis on a multifactorial approach, addressing the full spectrum of metabolic abnormalities, is a cornerstone of effective diabetes management and should be reflected in the design of a Roche diabetes care program.

Summary: Shifting the Paradigm in Diabetes Care

Although lowering glucose has been a long-standing primary focus in T2D management, achieving HbA1c targets alone has not proven sufficient to reduce mortality. Optimal diabetes management necessitates a multifactorial strategy that incorporates lifestyle interventions for weight control and early initiation of combination therapy. This approach should utilize multiple agents with different but complementary mechanisms of action to address the diverse metabolic abnormalities associated with T2D. Effective diabetes management must evolve beyond simply glucose control, requiring a paradigm shift towards a more comprehensive and patient-centered approach, principles that are central to the philosophy of a Roche diabetes care program.

Why and When We Need Randomized Controlled Trials and How We Can Improve Them: Refining the Gold Standard of Research

John Pickup from King’s College London addressed the critical role of Randomized Controlled Trials (RCTs) in medical research, while also highlighting their limitations and suggesting avenues for improvement. His lecture emphasized the need for robust trial design and execution to ensure the validity and applicability of research findings, considerations vital for the evidence-based development of programs like a Roche diabetes care program.

Background: The Ideal and the Reality of RCTs

RCTs are designed to minimize bias by randomly assigning patient characteristics and potential confounders to intervention and control groups. This randomization aims to isolate the intervention as the sole cause of observed outcome differences. While RCTs are widely regarded as the gold standard in research, serving as a potent marketing tool for industry and the foundation for cost-effectiveness calculations and regulatory approvals, it’s well-acknowledged that the perfect RCT remains an unattainable ideal.

Main Problems with RCTs: Design, Operations, and Organization

RCTs are particularly necessary when evaluating interventions with gradual or moderate effects in fluctuating conditions, and when observational data are conflicting. However, RCTs are prone to limitations that can compromise their value and lead to misleading interpretations and reporting. These limitations broadly fall into three categories: poor trial design, operational issues, and organizational issues.

Poor study designs can stem from various factors: lack of blinding (patient and investigator), introducing bias; underpowering (small sample size), limiting statistical significance; use of inappropriate, outdated, or poorly implemented treatments; poor external validity (study population not representative of the target population); inappropriate endpoints; and insufficient follow-up duration for accurate assessment. Pickup cited a 2009 meta-analysis of severe hypoglycemia in patients treated with multiple daily insulin injections (MDI) versus continuous subcutaneous insulin infusion (CSII) therapy as an example of design flaws.21 Among the 12 trials analyzed, several exhibited significant shortcomings, including underpowering, short durations, baseline imbalances, lack of washout periods in crossover designs, absence of allocation concealment, and discrepancies between individual patient data and published results. These design flaws underscore the importance of rigorous methodology in clinical research, principles that are essential for ensuring the reliability of evidence informing programs like a Roche diabetes care program.

Operational issues, such as slow and inadequate patient recruitment, are common challenges in RCTs. For instance, a significant percentage of internationally registered trials in women’s health and UK trials funded by the Medical Research Council (MRC) and the Health Technology Assessment Program failed to meet their planned sample sizes. Delayed enrollment often extends the duration of industry-sponsored trials considerably, increasing costs and time to completion.

Organizational issues, including complexity, bureaucratic hurdles, and time constraints, further complicate RCT execution. Staying current with rapidly evolving technologies poses a significant challenge, as trials using older generation CGM devices can become outdated even before publication. Cost is also a major concern, with phase 3 RCTs now averaging over $30 million USD. To mitigate costs, “adaptive” trial designs are gaining traction. These designs allow for prospective, planned modifications to the trial protocol based on accumulating data, potentially reducing costs and study duration while increasing study success. Other strategies include sample size reassessment to ensure adequate power, adjusting allocation ratios to favor more promising treatments, refining eligibility criteria, and early study termination when efficacy, safety, or futility is demonstrated. These operational and organizational considerations are crucial for conducting efficient and impactful clinical research, which is essential for the continuous improvement of diabetes care programs, including a Roche diabetes care program.

Summary: Enhancing RCT Validity and Efficiency

One approach to enhance the validity and efficiency of RCTs is the use of “pragmatic” clinical trials. These trials deliberately include a broader demographic and clinical range of patients (e.g., adults and children) and diverse study sites and skill sets (e.g., community and nonacademic centers). Following RCTs, real-world, observational studies can assess intervention effectiveness under typical clinical practice conditions. Combining both RCT and RWE approaches enables the establishment of an evidence-based pathway, first evaluating efficacy and then effectiveness. This combined approach, prioritizing both internal validity and real-world applicability, is crucial for developing and validating effective diabetes care programs, such as a Roche diabetes care program.

Pickup emphasized several key considerations for ensuring high-quality study designs. Sufficient statistical power and study duration are essential to determine result significance within a population of interest. Strategies to minimize recruitment challenges include telephone reminders, financial incentives, open allocation, and opt-out procedures. Pragmatic study designs are valuable for demonstrating external validity. Comparators should be current and relevant. Researchers should strive to minimize bias through blinding and allocation concealment to maximize recruitment and efficiency. Adaptive study designs should be considered to further reduce time and costs. By addressing these design, operational, and organizational challenges, RCTs can become even more valuable in generating robust evidence to guide and improve diabetes care practices and programs.

How Real-World Evidence Can Complement Randomized Controlled Trials: Expanding the Evidence Base for Diabetes Care

Kamlesh Khunti from the University of Leicester discussed the increasing importance of Real-World Evidence (RWE) in complementing Randomized Controlled Trials (RCTs) for a more comprehensive understanding of treatment effectiveness in diabetes management. His lecture highlighted how RWE can bridge the gap between the controlled environment of RCTs and the complexities of real-world clinical practice, providing valuable insights for programs like a Roche diabetes care program.

Overview: The Hierarchy of Evidence and the Role of RWE

Evidence-based guidelines traditionally rank meta-analyses of RCTs as the highest level of evidence (Level 1a), followed closely by well-designed RCTs (Level 1b). Consensus recommendations and reports are considered lower levels of evidence (Level 4). While RCTs provide crucial insights into intervention efficacy under ideal conditions, RWE assesses how interventions perform in routine clinical practice, measuring their effectiveness in “usual circumstances.”

There is a growing recognition of the value of RWE. A 2000 meta-analysis of RWE trials published in the New England Journal of Medicine concluded that well-designed observational studies do not systematically overestimate treatment effects compared to RCTs on the same topics.22 RWE is particularly valuable for investigating adverse events, especially rare events. A meta-analysis comparing adverse events from RCTs and observational studies found no significant difference in risk estimates between the two study types. This underscores the complementary nature of RCTs and RWE, and the importance of considering both in developing and evaluating comprehensive diabetes care programs, like a Roche diabetes care program.

RWD and RWE: Data Sources and Applications

Real-world data (RWD) are data collected outside the strict confines of RCTs. Sources of RWD include claims databases, medical records, patient registries, health surveys, and supplemental data from RCTs. Increasingly, RWD are being used to assess a broader range of outcomes, including quality-of-life measures, clinical outcomes, psychological factors, financial burden, adherence, and persistence.

Significant distinctions exist between RCTs and RWE studies. RCTs excel in providing internal validity, ensuring that observed effects are truly due to the intervention. RWE, on the other hand, offers generalizability to larger, more diverse populations, reflecting the heterogeneity of real-world patients and clinical settings. Cost is another key difference, with cardiovascular outcome trials (CVOTs) now averaging $150–$160 million, highlighting the potential cost-effectiveness of RWE studies in certain contexts.

RWE is gaining importance for various stakeholders, including prescribers, payers, patients, and regulatory agencies. However, regulatory agencies are still cautiously evaluating the extent to which RWE can support recommendations and product approvals. In diabetes, a notable example of regulatory clearance based on RWE was the use of metformin in patients with heart failure. These patients were historically excluded from metformin clinical trials due to concerns about lactic acidosis. However, reviews of observational studies demonstrated that metformin, compared to other treatments, was associated with a favorable adjusted risk ratio for all-cause mortality in this population. This example illustrates the power of RWE to address evidence gaps and inform clinical practice in areas where RCT data are limited, a crucial aspect for developing inclusive and effective programs like a Roche diabetes care program.

Low Representation of Patients in RCTs: Addressing the Generalizability Gap

RCTs often exclude elderly patients, individuals with comorbidities, and those taking multiple medications. However, only a small fraction of the overall diabetes population meets the strict inclusion criteria of many RCTs, raising concerns about the generalizability of RCT findings to real-world clinical practice. Moreover, RCT evidence is not always effectively translated into practice, even for patients who would have met RCT eligibility criteria. Furthermore, restrictive eligibility criteria in RCTs can exclude patients who might benefit most from an intervention, potentially underreporting the true magnitude of benefit. For example, studies with restrictive upper limits for baseline HbA1c may underestimate HbA1c reductions, as these reductions are generally greater in patients with higher baseline HbA1c. Similarly, weight loss with medications like GLP-1 receptor agonists may be underreported in RCTs that exclude patients with very high BMIs, as these patients often experience greater weight loss. Crucially, hypoglycemia event rates reported in RCTs are often significantly lower than those observed in global observational trials encompassing larger, more diverse populations not represented in RCTs. While RCT data have shown hypoglycemia reductions with newer glucose-lowering medications, a UK observational study showed no improvement in hospital admissions for hypoglycemia despite the increased use of these newer agents. These discrepancies highlight the importance of RWE in providing a more realistic picture of treatment effects in diverse patient populations, a critical consideration for programs aiming for broad impact, such as a Roche diabetes care program.

Improving Applicability to RWE from RCTs: Bridging the Gap

Confirmation of RCT findings in real-world settings is essential. For example, a 2010 RCT by Zoungas et al. demonstrated an association between severe hypoglycemia and increased risks of macrovascular or microvascular events and death in T2D patients.16 This finding was later corroborated by a real-world, retrospective cohort study of over 13,000 individuals with T1D and T2D, confirming the RCT findings and extending them to show no risk difference between diabetes types. Furthermore, the RWE study revealed a significantly higher CV event risk in patients with established CV disease compared to those without, a finding not reported in the original RCT. This example illustrates how RWE can validate and expand upon RCT findings, providing a more nuanced understanding of treatment effects in different patient subgroups, valuable for tailoring programs like a Roche diabetes care program to specific needs.

Another example is the 10-year follow-up study of the UK Prospective Diabetes Study (UKPDS) cohort, which demonstrated the “legacy effect” of early glycemic control on reducing long-term microvascular and macrovascular complications, even if glycemic improvements are not sustained over time. This effect was confirmed in a real-world analysis assessing the impact of early versus delayed therapy intensification on retinopathy and CV complications.

Comparative effectiveness studies further highlight the limitations of RCTs in representing real-world populations. For example, major SGLT-2 inhibitor trials showed benefits in reducing major adverse cardiac events in patients with atherosclerotic CV disease. However, only some of these trials included patients without established CV disease but with multiple risk factors, and these studies also showed beneficial effects. When considering heart failure hospitalizations, SGLT-2 inhibitor benefits are primarily observed in patients with renal compromise. While these findings are relevant to patients with CV and/or renal disease, the majority of diabetes patients in the real world do not have established CV disease. Moreover, patients enrolled in these trials often receive more comprehensive protective therapies (e.g., antihypertensives and statins) compared to typical real-world patients. This underscores the need for RWE to provide a more complete picture of treatment effectiveness in the broader, more heterogeneous diabetes population, informing the development of programs designed for real-world impact, like a Roche diabetes care program.

Summary: The Complementary Power of RWE

Well-designed real-world studies are crucial complements to RCTs. It’s essential to evaluate the totality of available evidence, considering the types and sources of RWD. More pragmatic trials, with greater representation of real-world populations, are needed to address specific research questions more effectively and reduce costs. As awareness of the strengths and limitations of RWE grows, methodologies for conducting these studies are continuously improving. By integrating insights from both RCTs and RWE, we can build a more robust evidence base for diabetes care, leading to more effective and relevant programs, such as a Roche diabetes care program, designed to meet the diverse needs of individuals living with diabetes in real-world settings.

Reversing Type 2 Diabetes Is Possible: Evidence, Limitations, and Dietary Interventions

Michael Lean from the University of Glasgow presented compelling evidence that type 2 diabetes (T2D) remission is achievable, particularly through structured weight management programs. His keynote lecture explored the evidence supporting diabetes reversal, its limitations, and the efficacy of dietary interventions, offering a hopeful perspective for diabetes management that aligns with the patient-empowering approach of a Roche diabetes care program.

Background: Challenging the Chronicity of T2D

T2D is often viewed as a chronic, progressive disorder requiring lifelong treatment. Despite clinical guidelines and medications aimed at managing HbA1c, blood pressure, and lipids, current approaches have not significantly improved life expectancy for T2D patients. Diagnosed at age 55, the average age of onset, individuals with T2D lose 5–6 years of life expectancy.

Weight gain and obesity are primary drivers of T2D development and progression. Bariatric surgeons have long observed diabetes remission (up to 75%) following significant weight loss, a finding now supported by RCTs. In 2008, Dixon et al. published the first RCT investigating bariatric surgery’s impact on weight loss and diabetes remission, demonstrating 83% remission with >15 kg weight loss.24

However, bariatric surgery is expensive and accessible to only a limited number of people. It also carries risks, with approximately one in four patients requiring additional surgery to address complications, and nearly all requiring lifelong medical support and micronutrient supplementation. This highlights the need for more accessible and less invasive approaches to achieve diabetes remission, a goal that a comprehensive Roche diabetes care program might address through lifestyle interventions and digital support.

Efficacy of Dietary Interventions: A More Accessible Path to Remission

Early T2D studies demonstrated that >15 kg weight reduction through dietary interventions could improve life expectancy to that of individuals without diabetes. Very low-calorie diets (VLCDs) can achieve similar results, although weight regain is a common challenge. However, a more recent study showed that extreme VLCDs may not be necessary; weight loss at 16 weeks was similar for individuals consuming 415 kcal/day and 810 kcal/day, suggesting adherence issues in both groups. Subsequent support programs revealed that structured meal replacement programs, rather than supervised exercise, significantly improved long-term weight maintenance. This emphasizes the critical role of dietary strategies and ongoing support in achieving and sustaining weight loss for diabetes remission, components that could be effectively integrated into a Roche diabetes care program.

A feasibility study in Scotland evaluated a primary care-based weight management program.25 The goal was >15 kg weight loss at 12 months in 91 patients with BMI ≥40 kg/m2. Patients started on a micronutrient-replete 810–833 kcal/day diet for 12 weeks or until 20 kg weight loss was achieved, followed by structured food reintroduction and weight-loss maintenance. At study end, one-third of patients achieved and maintained ≥15 kg weight loss. This intervention, which became a model for the National Health Service in Scotland, demonstrated weight loss efficacy comparable to bariatric surgery but with greater accessibility, highlighting the potential of structured dietary programs for broader impact, an approach that a Roche diabetes care program could leverage.

Diabetes Remission Clinical Trial (DiRECT): Evidence for Non-Surgical Remission

The Diabetes Remission Clinical Trial (DiRECT) specifically assessed diabetes remission in individuals with noninsulin-treated T2D using a nonsurgical, weight management program delivered in routine primary care settings in deprived areas of Scotland and Northern England.26,27 Patients aged 20–65 years with an average BMI of 35 kg/m2 were randomized to either the weight management program (n = 149) or usual best-practice care (n = 149).

The intervention involved a total liquid diet replacement (825–853 kcal/day formula diet) for the first 12 weeks, with biweekly 20- to 30-minute consultations with trained dietitians or nurses. The subsequent 12–18 weeks focused on a stepped transition to a food-based diet, a challenging phase as patients returned to eating habits that may have contributed to their diabetes. Biweekly dietitian/nurse consultations provided support during this transition. Weight-loss maintenance was initiated from weeks 19–104, with personalized energy prescriptions and guidance on food-based diets to stabilize weight and prevent regain.

At weeks 12–20, intervention patients experienced a mean weight loss of 14.5 kg. Some weight regain occurred over the study duration, with average weight losses of 11.6 kg at 12 months and 8.8 kg at 24 months. Remarkably, almost half (46%) of intervention patients achieved diabetes remission at 12 months, and 36% at 24 months. Among intervention patients maintaining >10 kg weight loss, remission rates reached 64% at 24 months. In contrast, remission rates in the control group remained low at 12 months (4%) and 24 months (3%). These significant remission rates achieved through a structured, non-surgical weight management program provide strong evidence for the reversibility of T2D in many individuals, a core message that a Roche diabetes care program could effectively communicate and implement.

Subanalyses of intervention patients in remission revealed significant reductions in liver fat and very low-density lipoprotein (VLDL-1) production rates, alongside improved first-phase insulin response. Significant improvements in HbA1c and blood pressure were observed with fewer medications compared to control patients. Other CV risk factors and quality of life also improved. Notably, the only safety signal in DiRECT was in the control arm, which experienced more serious adverse events in the second year than the intervention group. The cost of the intervention program was less than half the average healthcare cost of conventional diabetes treatment. DiRECT findings definitively demonstrate that diabetes remission can be achieved with >10 kg weight loss, making it a primary and achievable goal of diabetes care, a message of hope and empowerment that a Roche diabetes care program can effectively deliver.

Summary: T2D Remission as a Realistic Goal

T2D, while often characterized by ectopic fat accumulation, is not necessarily a permanent condition. Structured weight management programs capable of sustaining remission to a nondiabetic state are now a practical and important treatment target, offering significant personal benefits. Future research should focus on improving the achievement and maintenance of sufficient weight loss and expanding program scope to include diverse racial and ethnic groups with varying diabetes characteristics. The major challenge now is to allocate the necessary funds and resources to support diabetes remission services. Long-term data on the life-shortening complications of diabetes are essential to further solidify the benefits of remission-focused strategies. By embracing the evidence for diabetes remission, programs like a Roche diabetes care program can offer a more proactive and empowering approach to diabetes management, focusing on achieving and sustaining remission as a primary goal.

What Is and Why Do We Need Value-Based Health Care?: Examples from the Field of Diabetes

Tove Holm-Larsen from Pharma Evidence, Copenhagen, Denmark, explored the principles and benefits of value-based health care, particularly in the context of diabetes management. Her lecture emphasized the shift from traditional volume-based care to a patient-centered approach focused on outcomes and value, a perspective highly relevant to the development and implementation of a Roche diabetes care program.

Background: The Rising Costs and Evolving Needs of Health Care

Healthcare costs are escalating across the Western world, driven by factors like aging populations, the obesity epidemic, and advancements in personalized medicine. Personalized medicine, while promising, is fragmenting broad disease areas like breast cancer into numerous, highly specific rare diseases, demanding new diagnostic and treatment technologies. Western societies are facing increasing challenges in affording these rising healthcare costs.

Why Value-Based Health Care Is Needed: Shifting the Focus to Outcomes

The traditional institution-based approach to healthcare, primarily driven by economics and budgeting, focuses on efficiency in capital expenditures but lacks incentives for improving care quality. Activity-based approaches, emphasizing bureaucratic and staff activity, often result in extended waiting times and minimal incentives for outcome improvement.

Value-based health care represents a paradigm shift, focusing on the individual patient rather than solely treating illness. For chronic conditions like diabetes, value-based care emphasizes personalized treatments tailored to individual clinical needs. The core idea is that even if a treatment is initially more expensive, its effectiveness in rapidly improving diabetes control can reduce the significantly higher long-term costs associated with diabetes complications. Value-based care extends further, promoting diabetes prevention, leading to even greater cost savings. This preventative and outcome-oriented approach aligns perfectly with the principles of a comprehensive and effective Roche diabetes care program.

Institutions adopting value-based healthcare are incentivized to improve outcomes across the entire care continuum. While cost efficiencies can be challenging to measure directly, this approach offers numerous benefits to all stakeholders. Patients benefit from lower costs and improved outcomes. Providers experience higher patient satisfaction and care efficiency, with financial incentives for prevention. Payers gain stronger cost controls and reduced risk. Suppliers see greater alignment of prices with patient outcomes. Society benefits from reduced healthcare spending and overall improved population health. These multifaceted benefits underscore the compelling rationale for transitioning to value-based healthcare models, particularly in chronic disease management, and for incorporating these principles into programs like a Roche diabetes care program.

Changing the Paradigm: Key Steps for Implementation

Initiating value-based healthcare requires a fundamental rethinking of the healthcare system. Patient care must provide clinical-grade feedback on patient status and clear treatment instructions. Services and care must be closely coordinated using real-time data. Patient outcomes and engagement must be measurable. Crucially, the clinical environment must foster proactive collaboration between healthcare providers and patients.

Holm-Larsen outlined six key steps for successful implementation of value-based healthcare: (1) organize treatment into integrated units; (2) calculate results and costs on a per-patient basis; (3) establish bundled payments per overall treatment; (4) integrate previously siloed healthcare services/sectors; (5) establish community centers facilitating prevention and therapy adherence support; and (6) utilize integrated, well-functioning information technology (IT) solutions for information and data sharing. These steps provide a practical roadmap for healthcare systems to transition towards value-based care, and for programs like a Roche diabetes care program to adopt and promote these principles.

The underlying principles of value-based healthcare include: payment for outcomes, not processes; risk-sharing among stakeholders (providers, payers, pharmaceutical/device companies) to ensure fairness across sectors; and securing agreement among key decision-makers. Implementation must be patient-centered and scalable, regardless of patient volume. Value calculation must be continuous and transparent to all stakeholders. The invoicing structure must be functional for all parties. Reimbursement should be based on common outcome measures, with higher reimbursements for exceeding defined outcome levels and lower reimbursements for falling short. These principles emphasize accountability, patient-centricity, and collaborative partnerships, all essential components of a successful value-based healthcare system and a program like a Roche diabetes care program.

Summary: Patient-Centricity and Cost Savings through Value-Based Care

Value-based healthcare promotes true patient centrism by prioritizing individual patients and enhancing incentives for follow-up and risk reduction. This approach offers significant cost-saving potential by focusing on high-risk patients and providing leverage in medication cost negotiations. While implementing value-based healthcare can be complex, innovative digital solutions can facilitate the transition. By embracing value-based principles, healthcare systems and programs like a Roche diabetes care program can move towards more efficient, effective, and patient-centered diabetes care delivery, ultimately improving outcomes and reducing the overall burden of diabetes.

Connecting the Dots for Outcome-Based Diabetes Management: Bridging the Efficacy-to-Effectiveness Gap

Kamlesh Khunti, in his second lecture, addressed the crucial need to connect evidence-based guidelines with real-world outcomes in diabetes management. He focused on the “efficacy-to-effectiveness gap”—the difference between results seen in RCTs and those observed in clinical practice—and strategies to bridge this gap, highlighting the importance of implementation science for programs like a Roche diabetes care program to achieve their intended impact.

Background: Evidence-Based Guidelines and Implementation Challenges

Evidence-based guidelines are developed to evaluate variations in care and assess efficacy and effectiveness gaps for both population-level and pharmaco-effectiveness interventions. These guidelines then recommend strategies to improve the efficacy-to-effectiveness gap. Implementation research focuses on the effects of purposeful actions to translate new treatments, practices, and services into real-world settings. Implementation outcomes serve as indicators of implementation success, proximal indicators of implementation processes, and key intermediate outcomes in treatment effectiveness and quality-of-care research. Understanding and addressing implementation challenges is crucial for ensuring that programs like a Roche diabetes care program effectively translate evidence into improved patient outcomes.

Numerous RCTs have demonstrated that glucose-lowering therapies improve glycemic control and reduce microvascular and macrovascular complications, particularly when initiated aggressively early in the disease course.12,13,28,29 These findings have informed clinical guidelines, such as the European Association for the Study of Diabetes (EASD)/American Diabetes Association (ADA) consensus guidelines for T2D management, which include algorithms for medication intensification. However, a critical element often overlooked in these guidelines is the explicit caution to clinicians to reassess patients and modify treatment every 3–6 months to avoid clinical inertia.30 Despite the availability of robust evidence and clear guidelines, a significant efficacy-to-effectiveness gap persists in diabetes care.

Efficacy-to-Effectiveness Gap: A Persistent Challenge

Despite high-quality evidence and international guidelines, many patients fail to achieve risk factor targets in routine clinical practice. The GUIDANCE study revealed that while 90% of included diabetes patients had HbA1c measurements, only 38%–70% (depending on the country) achieved HbA1c targets.31 UK data from electronic health records of over 3 million diabetes patients showed that only 50% met all eight process measures for T2D management (smoking cessation, BMI reduction, foot examinations, urine albumin, creatinine, cholesterol, blood pressure, and HbA1c). Less than 40% achieved all three treatment targets for HbA1c, blood pressure, and lipids. This persistent gap between evidence and practice underscores the need for targeted strategies to improve implementation, a central focus for programs like a Roche diabetes care program aiming to translate research into real-world impact.

Several factors contribute to this efficacy-to-effectiveness gap, primarily therapeutic inertia and adherence to therapies. Underlying reasons for this gap include population differences, biological differences (e.g., variability in drug response), and behavioral differences, with behavioral factors often being the most influential.

Diabetes prevention trials illustrate how population differences can impact outcomes. A 2007 meta-analysis concluded that lifestyle changes and pharmacological interventions can reduce T2D progression in individuals with impaired glucose tolerance.32 However, a systematic review of real-world diabetes prevention interventions showed significant variation in effect size.33 While weight reductions were achievable, few studies demonstrated actual diabetes prevention in real-world settings. Furthermore, participants in these studies were often highly motivated, unrepresentative of the general population. Interventions were also frequently time-intensive and not feasible in routine clinical practice. A case study of the Diabetes Prevention Program showed an exponential decline in intervention use, staff participation, patient willingness to participate, and adherence to the regimen, ultimately resulting in a small percentage of patients benefiting long-term. These challenges highlight the difficulties in translating even well-established interventions into broad population-level impact, emphasizing the need for tailored implementation strategies within programs like a Roche diabetes care program.

Inertia: A Barrier to Optimal Therapy Intensification

Failure to intensify therapy when needed, or deintensify when appropriate, is a major contributor to the efficacy-to-effectiveness gap. Deintensifying therapy is particularly important in older adults. A 2013 retrospective study examining inertia in poorly controlled T2D found median times to intensification of 2 years from one oral agent to two, 7.2 years from two to three orals, and 6 years from two to three orals to insulin, despite persistent HbA1c levels ≥7.5%.34 Other studies have shown similar delays in insulin initiation and titration. A significant consequence of therapeutic inertia is that patients who fail to reach their HbA1c target within the first 3 months are less likely to reach it at 24 months. Addressing therapeutic inertia through education, decision support tools, and streamlined clinical workflows is crucial for improving diabetes management and enhancing the effectiveness of programs like a Roche diabetes care program.

Adherence: A Critical Determinant of Treatment Success

Suboptimal adherence is another major driver of the efficacy-to-effectiveness gap. RCTs of GLP-1 receptor agonists consistently show HbA1c reductions of approximately 1.0%. However, a real-world analysis by Carls et al. found reductions of only 0.52%.35 Statistical modeling indicated that roughly 75% of the gap between efficacy and effectiveness of GLP-1 receptor agonists was attributable to poor adherence. A systematic review of 8 observational studies reported a mean poor adherence rate of 37.8%.36 Improving treatment adherence through patient education, simplified regimens, and addressing patient-specific barriers is paramount for closing the efficacy-to-effectiveness gap and maximizing the impact of programs like a Roche diabetes care program.

Closing the Gap: Strategies for Improved Outcomes

Barriers to treatment adherence are multifaceted, including patient perceptions of therapies, reduced quality of life, concerns about side effects, complex regimens, and financial limitations.37 While patient education and support interventions are important, closing the efficacy-to-effectiveness gap requires strategies to reduce inertia, such as developing more meaningful quality measures, leveraging information systems more effectively, providing personalized feedback to clinicians, and streamlining access to patient data in easily interpretable formats. Digital health solutions, decision support tools, and patient-centered communication strategies are all crucial components of a comprehensive approach to bridging this gap and enhancing the real-world impact of diabetes care programs, including a Roche diabetes care program.

Summary: Individualizing Therapies and Interventions

Early preventative interventions to achieve optimal diabetes control are associated with long-term clinical benefits. However, significant efficacy-to-effectiveness gaps persist in real-world settings, with numerous barriers hindering the translation of evidence into practice. Addressing these barriers requires a multifaceted approach, with the key being individualizing not just therapies, but also the interventions themselves to meet the specific needs of each patient. Programs like a Roche diabetes care program should prioritize personalized approaches, focusing on both effective therapies and tailored implementation strategies to bridge the efficacy-to-effectiveness gap and optimize patient outcomes in real-world settings.

Digitally Enabled Diabetes Management Facilitates State-of-the-Art Personalized Care: Leveraging Technology for Improved Outcomes

Valérie Babinsky from Roche Diabetes Care, Vienna, Austria, highlighted the transformative potential of digitally enabled diabetes management in facilitating state-of-the-art personalized care. Her lecture focused on how digital solutions can address key challenges in diabetes management, such as clinical inertia and poor adherence, and enable more patient-centered and effective care delivery, aligning with the innovative spirit of a Roche diabetes care program.

Background: Addressing the Efficacy-to-Effectiveness Gap with Digital Tools

Despite advancements in medications, glucose monitoring technologies, and insulin delivery systems, a significant proportion of individuals with diabetes, often cited as 50%–70%, still fail to achieve their glycemic targets. This persistent gap between potential and real-world outcomes underscores the need for innovative approaches, particularly those leveraging digital technologies, to enhance diabetes management and improve patient outcomes.

Drivers of the Efficacy-to-Effectiveness Gap: Clinical Inertia and Poor Adherence

A primary driver of suboptimal diabetes control is clinical inertia, the failure to intensify therapy when clinically indicated.38 Reasons for clinical inertia include insufficient time during routine clinical visits for adequate patient assessment and counseling, fragmented or poorly structured clinical information, resource constraints, and a lack of holistic, patient-centric care processes. Furthermore, poor patient adherence to therapy is a major contributor to the efficacy-to-effectiveness gap.35 These challenges highlight the need for solutions that can streamline clinical workflows, provide readily accessible and actionable patient data, and empower patients to actively engage in their diabetes management, areas where digital health tools can play a transformative role, particularly within the context of a Roche diabetes care program.

The World Health Organization defines adherence as “the extent to which a person’s behavior—taking medication, following a diet, and/or executing lifestyle changes—corresponds with the agreed recommendations from a health care provider.” Adherence is inversely proportional to disease burden and is influenced by intentional factors (e.g., avoiding side effects, regimen complexity) and unintentional factors (e.g., forgetfulness, difficulty changing lifestyle behaviors).39 Both clinical inertia and poor adherence are significantly influenced by a lack of actionable data. While healthcare data volume has increased dramatically in recent years, this data often remains scattered and difficult to interpret, hindering timely and effective clinical decision-making. A pilot study revealed that over 50% of patients with comorbid T2D, hypertension, and impaired kidney function were not receiving guideline-conform care for hypertension, highlighting the challenges of managing complex, multi-morbidity in routine clinical practice. Digital solutions that aggregate and visualize data, providing clinicians with a comprehensive and actionable patient overview, are crucial for overcoming these challenges and improving care quality, a core focus for a digitally-enabled Roche diabetes care program.

Integrated Personalized Diabetes Management (iPDM): A Patient-Centric Approach

To address clinical inertia and promote patient-centered care, the EASD/ADA guidelines recommend a personalized approach to diabetes management, emphasizing patient empowerment and collaborative decision-making between healthcare teams and individuals with diabetes. The PDM-ProValue study evaluated the feasibility of this concept, demonstrating that a structured personalized approach, termed Integrated Personalized Diabetes Management (iPDM), significantly improved clinical outcomes through earlier and more frequent therapy adjustments.40 iPDM places the patient at the center of a circular care pathway, fostering shared decision-making and close integration of all essential stakeholders. A key driver of therapy intensification in the iPDM approach was increased patient adherence, which coincided with enhanced treatment satisfaction and improved patient-clinician interactions, both known to positively influence adherence. Clinicians also reported increased satisfaction with the iPDM approach compared to usual care, suggesting that patient-centered, collaborative models of care can benefit both patients and providers, principles that are central to the design and delivery of a Roche diabetes care program.

Digital Solutions: Enabling Data-Driven and Collaborative Care

Digital solutions are essential for overcoming the lack of oversight and fragmented data that contribute to clinical inertia and suboptimal diabetes management. Targeted data aggregation and visualization, as demonstrated by the Accu-Chek Connect Reports Utility and Efficiency Study (ACCRUES), can lead to faster and more impactful therapy decisions.

As evidenced by the PDM-ProValue study, the most promising healthcare applications provide digital solutions that efficiently collect and organize data automatically, presenting it in formats that facilitate rapid patient assessment and informed therapy decision-making.40,41 These solutions should also support collaboration and shared decision-making, empowering patients to become more knowledgeable and engaged in their treatment, and enabling clinicians to identify and address patient-specific barriers to adherence. Digital platforms that provide immediate access to structured data, enhanced by decision support tools, foster greater collaboration and more informed shared decision-making. Crucially, these digital solutions must integrate all aspects of diabetes patient care, including comorbidities like hypertension and dyslipidemia, which are often overlooked in busy clinical settings due to time constraints and challenges in accessing and assessing comprehensive patient information during clinic visits. By automating time-consuming data management tasks, digital solutions free up valuable time for more meaningful patient-clinician interactions, a key benefit for both patients and providers within a digitally-enabled Roche diabetes care program.

Enhanced Care through Connectivity: Building an Open Ecosystem

While many existing digital solutions remain closed systems, hindering interoperability, Roche Diabetes Care is actively building an open ecosystem to facilitate interconnectivity between various technologies from diverse device manufacturers and app/software developers. The ultimate goal is to minimize the efficacy-to-effectiveness gap by providing timely and effective information to physicians and empowering patients in their self-management. This commitment to open connectivity and data sharing reflects a forward-thinking approach to digital health, aiming to create a more integrated and user-friendly ecosystem for diabetes care, potentially through initiatives within a broader Roche diabetes care program.

Summary: Revolutionizing Diabetes Management with Digital Transformation

Leveraging the exciting opportunities presented by the digital transformation of healthcare holds immense potential to revolutionize diabetes management. Digital solutions can foster shared decision-making between clinicians and patients, ensure the provision of effective and efficient routine care, and ultimately improve outcomes for individuals living with diabetes. By embracing digital innovation and prioritizing patient-centered, data-driven approaches, programs like a Roche diabetes care program can lead the way in transforming diabetes care in the digital age.

Predicting the Early Risk of Chronic Kidney Disease in People with Diabetes Using Real-World Data: Advancing Risk Assessment with Data-Driven Algorithms

Wolfgang Petrich from Roche Diagnostics, Penzberg, Germany, discussed the application of Real-World Data (RWD) in developing algorithms to predict the early risk of chronic kidney disease (CKD) in people with diabetes. His lecture highlighted the potential of RWD to improve risk assessment accuracy and personalize care, leading to earlier and more targeted interventions, a key aspect of a proactive Roche diabetes care program.

Overview: Early Risk Assessment for Personalized Interventions

Early medical risk assessment is crucial for facilitating more focused clinician-patient interactions and enabling earlier, more targeted interventions, ultimately leading to improved clinical outcomes. Current treatment recommendations and risk stratifications are often based on tightly controlled randomized trials, frequently involving preselected patients and conducted under ideal conditions. Consequently, outcomes from these trials may not fully reflect intervention effectiveness in diverse real-world populations.

While the volume of RWD from clinics and physician offices significantly exceeds clinical trial data, this increase in volume often comes at the expense of data completeness, uniformity, and control. Roche Diagnostics partnered with IBM to develop and evaluate an algorithm using RWD to more accurately assess CKD risk compared to using HbA1c alone or algorithms based solely on clinical trial data. This collaboration exemplifies the power of data-driven approaches to enhance risk prediction and personalize diabetes care, a core principle of a forward-thinking Roche diabetes care program.

Assessing the Risk for CKD: A Data-Driven Approach

A recent study explored the use of RWD to identify individuals with diabetes at high near-term risk of developing CKD.42 The analysis compared an algorithm derived from patient records of 417,912 individuals with newly diagnosed T1D or T2D from the IBM Explorys database with algorithms based on four large clinical trials. The Roche/IBM algorithm prioritized seven features—age, BMI, glomerular filtration rate, HbA1c, glucose, and creatinine and albumin concentrations—as key risk predictors, based on both data-driven insights and medical expertise. The algorithm was then validated using data from 104,504 independent individuals from the IBM Explorys database and 82,912 T2D patients from the Indiana Network for Patient Care (INPC) database. This robust validation process underscores the rigor and reliability of the RWD-driven algorithm, enhancing its potential for clinical application within programs like a Roche diabetes care program.

The area under the receiver operating characteristic curve (AUC), a common measure of clinical marker quality, was used to evaluate the algorithms’ ability to accurately predict CKD risk over the subsequent 3 years. Using the seven prioritized measures, the Roche/IBM algorithm achieved an AUC of 76%. In the same population, HbA1c alone yielded an AUC of only 57%. Investigators also assessed the algorithm’s prediction capabilities in subcohorts matching the inclusion and exclusion criteria of the clinical trials. In these subcohort analyses, the Roche/IBM algorithm consistently outperformed algorithms derived from clinical trials. This superior performance highlights the value of RWD-driven algorithms in providing more accurate and clinically relevant risk predictions compared to traditional approaches, a significant advancement for personalized diabetes care and programs like a Roche diabetes care program.

Recognizing that complete data for all seven predictors may not always be available in real-world clinical practice, investigators also explored the algorithm’s prediction capabilities with data gaps. Using the INPC database, an AUC of 80% was achieved when all parameters were present, which remained relatively stable even when as few as 30% of the parameters were available. Further analysis suggested that the superior performance of the Roche/IBM algorithm was not solely due to the size of the cohort used for development, but potentially more attributable to the diversity of the training data. This robustness and resilience to missing data enhance the algorithm’s practical applicability in diverse clinical settings and its potential integration into programs like a Roche diabetes care program.

Summary: RWD-Driven Algorithms for Improved CKD Risk Prediction

The Roche/IBM algorithm demonstrably outperforms algorithms published in the literature in both real-world cohorts and subcohort analyses, achieving an AUC of 79% in predicting CKD development within 3 years of diabetes diagnosis. Importantly, accuracy remains only slightly affected even when fewer than all seven predictive factors are available to clinicians. These findings further fuel the ongoing debate regarding the efficacy and efficiency of using RWD compared to clinical trial data. They strongly support the value of leveraging RWD, potentially in combination with clinical trial data, for medical risk assessment. By integrating RWD-driven algorithms into diabetes care programs, such as a Roche diabetes care program, healthcare providers can achieve more accurate early risk stratification, enabling more personalized and proactive interventions to prevent or delay the onset of CKD in individuals with diabetes, ultimately improving long-term outcomes and reducing the burden of this serious complication.

The PRO Solo Study: Hands-on Experiences with a New Micropump – Advancing Insulin Delivery Technology

Julia Mader from the Medical University of Graz, Graz, Austria, presented on the PRO Solo study, focusing on the setup and initial experiences with the Accu-Chek® Solo micropump system, a novel patch pump technology. Her lecture highlighted the potential benefits and practical considerations of this new micropump, relevant to the technological advancements supported and potentially integrated within a Roche diabetes care program.

Background: The Rise of Insulin Pump Therapy

Insulin pump use in adults and children has been steadily increasing in recent years, driven primarily by improvements in convenience, ease of use, and reimbursement policies. Patients often find pumps a more comfortable and discreet method of insulin delivery, leading to improved adherence to bolus dosing, particularly for snacks and minor glucose corrections, which are often missed with pen injections. This improved bolus adherence, especially when combined with continuous glucose monitoring (CGM), often results in better glycemic control for many patients. These factors contribute to the growing adoption of insulin pump therapy and its potential role within comprehensive diabetes care programs, including a Roche diabetes care program.

Patch Pump versus Conventional Pump: Weighing the Advantages and Limitations

Currently, two main types of insulin pumps are available: conventional pumps, which require an infusion set to deliver insulin subcutaneously, and patch pumps, which attach directly to the skin with an adhesive and deliver insulin through an integrated Teflon cannula. Patch pumps offer several advantages over conventional pumps. Their tubeless design eliminates common issues associated with infusion sets, such as kinks and clogs, and reduces the risk of infusion site problems. Many patch pump systems allow for both manual and remote-controlled insulin administration. Studies have indicated that patch pump application is often perceived as less painful than infusion set insertion. The smaller size and diverse placement options on the body provide greater convenience and discretion for users. These advantages make patch pumps an appealing alternative for many individuals considering insulin pump therapy, and potentially a valuable component within a Roche diabetes care program offering advanced technology options.

However, patch pumps also have limitations. Users often need to carry extra supplies when traveling. If a pump cartridge is filled with more insulin than needed, any remaining insulin is wasted when the pump is replaced. The insertion site is not directly visible, potentially increasing the risk of undetected infections or cannula dislocations. While many patch pumps are water-resistant, they typically need to be removed for swimming. These limitations are important considerations for both patients and healthcare providers when evaluating patch pump therapy and for program developers considering their inclusion in a Roche diabetes care program.

Accu-Chek® Solo Micropump System: A Modular Patch Pump Innovation

The Accu-Chek Solo micropump system represents the latest advancement in patch pump technology. It received CE-approval in 2018 and has been launched in select markets. Currently, it is being assessed in a multinational clinical trial in Europe.

The Accu-Chek Solo system features a modular design with two wirelessly communicating components: the micropump and the Diabetes Manager (a handheld remote control device). The micropump includes a reusable pump base, designed for up to 4 months of use, with a disposable 2 mL (200 IU) insulin reservoir attached. The pump base houses the motor, electronics, memory, bolus buttons, and safety alerts—components typically found in conventional insulin pumps. Bolus buttons on the micropump allow users to administer boluses directly without needing the Diabetes Manager. Subcutaneous tissue connection and body fixation are achieved via an infusion assembly available with 6- or 9-mm cannulas. The modular design allows for temporary micropump disconnection (e.g., during exercise) and replacement of individual system components as needed. This modularity and user-friendly design are key features of the Accu-Chek Solo, potentially making it a valuable addition to the insulin delivery options offered within a Roche diabetes care program.

PRO Solo Study: Evaluating the Accu-Chek® Solo Micropump

The Accu-Chek Solo micropump system is currently under evaluation in the PRO Solo study, a prospective, multicenter, multinational trial assessing its impact on treatment satisfaction and glycemia compared to multiple daily injections (MDI) in 180 insulin pump-naïve individuals with T1D. Participants are randomly assigned to the Accu-Chek Solo micropump, Insulet OmniPod® insulin management system, or continued MDI therapy. After 6 months, all participants will transition to the Accu-Chek Solo micropump system for an additional 13 weeks. The primary outcome measure is change in treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Secondary outcomes include device satisfaction, device performance, hypoglycemia, HbA1c, and material consumption. The PRO Solo study provides crucial clinical data to evaluate the efficacy, safety, and user experience of the Accu-Chek Solo micropump, information valuable for informing its potential role within a Roche diabetes care program.

As of April 2019, the study had enrolled 124 participants, with 14 completing the study and 8 discontinuing (only 1 in the Solo group). Preliminary feedback from participants has been positive. Most found the Solo micropump small, discreet, and easy to handle. The tubeless design and manual bolus delivery capability were also highly rated. However, the lack of waterproofing and smartphone control were considered disadvantages. These initial user experiences provide valuable insights for further development and refinement of patch pump technology and for understanding patient preferences in insulin delivery systems, considerations relevant to the technological offerings within a Roche diabetes care program.

Requirements for Switching from MDI to CSII: Patient and Provider Considerations

Appropriate candidates for insulin pump therapy are typically motivated individuals with good diabetes knowledge and established self-management and problem-solving skills. Healthcare providers should be experienced in technology, particularly insulin pumps, and have a support team comprising a diabetologist, diabetes educator, and dietitian familiar with both the system and reimbursement requirements. Manufacturer technical support is also essential. These patient and provider requirements are important considerations for healthcare systems and programs like a Roche diabetes care program when implementing and supporting insulin pump therapy.

The first step in initiating insulin pump therapy is collaborative goal setting with patients to agree on glycemic targets. Basal dose calculation is the next step. For patients already on insulin therapy with good glycemic control, a 20% basal dose reduction may be considered. If glycemic control is suboptimal, dose adjustments may be needed. Age, body weight, and physical activity level are additional factors in determining total daily dosages and setting time blocks. It’s crucial to counsel patients that glycemic changes may not be apparent until approximately 3 hours after basal insulin adjustments, which is important for guiding temporary rate adjustments. Temporary basal rates or profiles for situations requiring lower rates (e.g., exercise, alcohol use) and higher rates (e.g., high-fat meals, stress, illness) should also be calculated and programmed. Starting points are generally 150% for increases and 50% for reductions. These detailed considerations for insulin pump initiation and management are essential for ensuring safe and effective use, and should be incorporated into training and support materials within a Roche diabetes care program.

Bolus insulin requirement determination is the next step. Common basal-to-bolus ratios are 30:70, but can range from 60:40 to 50:50. For patients with well-controlled diabetes, current bolus doses may not need adjustment. Doses can also be estimated using insulin-to-carbohydrate ratios (350 ÷ Total Daily Dose for obese; 500 ÷ Total Daily Dose for lean) or insulin sensitivity factors (ISF) (500 ÷ Total Daily Dose for obese; 2000 ÷ Total Daily Dose for lean).

The primary goal of diabetes management is to prevent hypoglycemia, often caused by excessive glycemic variability due to overcorrection, early insulin administration for hyperglycemia, or premature bolus delivery. Patients must be thoroughly educated about these risks and trained to use bolus calculators, understanding insulin-on-board timeframes. Effective patient education and training are paramount for safe and successful insulin pump therapy, and should be a core component of any program offering this technology, including a Roche diabetes care program.

Summary: Patch Pumps as an Effective and Comfortable Alternative

With proper training and accurate insulin parameters, insulin pump therapy can be safely used to achieve optimal glycemic control. Patch pumps, like the Accu-Chek Solo, offer an effective and comfortable alternative to conventional insulin pumps, potentially expanding access to pump therapy and improving patient satisfaction. Continued innovation in insulin delivery technology, like patch pumps, and comprehensive patient support programs, such as a Roche diabetes care program, are crucial for advancing diabetes management and improving the lives of individuals with diabetes.

Insertable Real-Time Continuous Glucose Monitoring at a New Level: Clinical Benefits of a 6-Month Sensor Wearing Time

Dorothee Deiss from Medicover Berlin, Berlin, Germany, presented on the Eversense® real-time CGM system, highlighting the clinical benefits of its unique 6-month sensor wear time. Her lecture emphasized how this long-term insertable CGM system addresses key barriers to CGM adoption and adherence, potentially revolutionizing glucose monitoring and aligning with the patient-centric and innovative approach of a Roche diabetes care program.

Overview: CGM Benefits and Unmet Needs

Continuous Glucose Monitoring (CGM) has demonstrated significant benefits, including improved HbA1c, increased time in target glucose range, and reduced hypoglycemia. Despite these well-established advantages, CGM adoption remains limited, particularly in T1D and even more so in T2D. Furthermore, adherence and persistence with CGM use are often poor, with a significant percentage of users discontinuing within the first year. These low adoption and adherence rates underscore the need for CGM systems that are more user-friendly, less burdensome, and better address patient needs, areas where innovative solutions like the Eversense system and programs like a Roche diabetes care program can make a significant impact.

Unsolved Issues with CGM Systems: Barriers to Adoption and Adherence

Reasons for CGM discontinuation include the burden of frequent sensor insertions (25 to 50 times per year), fear of pain or discomfort during insertion, risk of accidental sensor dislocation, missed alarms, and increasing reports of skin reactions and allergies to adhesives. An ideal CGM sensor would feature a longer sensor life, require minimal insertions, and have a transmitter that is easy to wear and remove as needed. These unmet needs highlight the market opportunity for innovative CGM technologies that can overcome these barriers and improve patient experience, a focus that drives innovation within programs like a Roche diabetes care program.

Senseonics Eversense® Real-Time CGM System: A Long-Term Implantable Solution

The Eversense real-time CGM (rtCGM) system (Senseonics, Inc., Germantown, MD) directly addresses the barriers to rtCGM use and has the potential to encourage wider CGM adoption among individuals with diabetes. It is currently the only commercially available long-term CGM system with a fully implantable sensor lasting up to 180 days. The system provides on-body vibration alerts if individualized high- and low-glucose thresholds are breached. The sensor is implanted in the upper arm through a minimally invasive procedure. Users can temporarily remove the external transmitter, for example, for discreet use or physical activity, without needing to replace the sensor. These features significantly reduce the burden of CGM use, potentially improving adherence and patient satisfaction, and making the Eversense system a valuable technology to consider within a Roche diabetes care program focused on advanced monitoring solutions.

The Eversense system comprises three components: the implantable sensor, a “smart” transmitter, and a mobile app. Sensor implantation and removal are performed during a brief, minimally invasive, office-based procedure using customized insertion tools. The sensor technology is fluorescence-based, unlike the electrochemistry used in most other CGM systems, eliminating acetaminophen interference. The sensor is powered by the small, externally worn transmitter, secured with a daily-changed silicone-based adhesive for comfort. The mobile app, compatible with smartphones and Apple Watches, provides real-time glucose readings every 5 minutes, glucose trends, and alerts, including predictive alerts. The Eversense® NOW app allows caregivers and healthcare providers to remotely view patient glucose data, enhancing remote monitoring and care coordination, features that could be leveraged within a digitally-integrated Roche diabetes care program.

Efficacy and Safety: Robust Clinical Evidence

The accuracy and safety of the Eversense system have been demonstrated in both T1D and T2D patients over 90- and 180-day periods (masked and unmasked modes) in a pivotal European trial43 and two US trials.44,45 Extensive data from the European PRECISE trial43 were used to refine the algorithm accuracy, which was shown to be comparable to other CGM systems46 in the subsequent PRECISE II44 and PRECISION studies.45 Consistent accuracy over 180 days was also demonstrated in a primarily adolescent population.47 The new 602 algorithm, further enhancing sensor life performance, is now available in the US and recently introduced in Europe. This robust clinical evidence base supports the efficacy and reliability of the Eversense system as a long-term CGM solution, making it a potentially valuable component of a comprehensive Roche diabetes care program.

Across all these studies, the Eversense system demonstrated a strong safety profile. Insertion and removal procedures and the device itself were well-tolerated, with no adverse events related to insertion/removal or the device itself. Infections were absent, and only a few mild skin reactions to the sensor occurred, resolving within 2–8 weeks of removal. Limited skin reactions to the transmitter adhesive were also observed. Ongoing European registry data further confirm the system’s safety, with reported adverse events similar to those seen with other CGM systems. This strong safety profile is a crucial factor for patient acceptance and clinical adoption, and for considering the Eversense system within a Roche diabetes care program.

Germany Experience: Positive Patient Feedback

Currently, over 300 Eversense centers are operating in Germany, with more than 1800 patients using the system. Patients at the Berlin clinic have reported high satisfaction with the Eversense system, highlighting key benefits such as extended sensor longevity, consistent accuracy, no sensor loss during transmitter removal, and fewer false nighttime alarms. Users also appreciate the removable transmitter, particularly the on-body alerts, which function even when a smartphone is not nearby. Tape adherence and reduced skin irritation were also cited as positive features. Patients also expressed satisfaction with the app, compatible with both iOS and Android platforms, and its event logging (food intake, exercise) and data sharing capabilities. Preterm sensor failure and scarring at the insertion site were identified as rare concerns, and some patients expressed dissatisfaction with daily transmitter battery charging. These real-world patient experiences provide valuable feedback for system improvement and for understanding patient preferences in long-term CGM use, informing the potential integration of the Eversense system within a Roche diabetes care program.

Patient Selection Criteria: Identifying Ideal Candidates

Patients best suited for the Eversense system are typically comfortable and consistent smartphone users. Beyond general CGM selection criteria, specific characteristics suggest patients who would particularly benefit from long-term rtCGM: individuals who find frequent sensor replacements burdensome and those at high risk of disengaging from external sensors. History of skin problems, fear of pain or needles, and the need for on-body alerts (e.g., drivers, athletes, hearing impaired) are also indications for Eversense use. These patient selection criteria are important for ensuring appropriate use and maximizing the benefits of the Eversense system, and for guiding its targeted implementation within a Roche diabetes care program.

Summary: Eversense as a Significant Advancement in CGM Technology

The Eversense system offers significant advantages over other CGM systems, representing an important addition to the CGM landscape. Its extended sensor life, improved user experience, and robust clinical evidence base have the potential to expand CGM penetration, enabling more patients to embrace CGM and achieve better glycemic control. By addressing key barriers to CGM adoption and adherence, the Eversense system, and programs like a Roche diabetes care program that incorporate such innovative technologies, can contribute significantly to advancing diabetes management and improving patient outcomes.

Automated Insulin Delivery and Decision Support Systems: Moving from Science to Clinical Practice

Jessica Castle from Oregon Health & Science University, Portland, Oregon, provided an overview of the advancements in automated insulin delivery (AID) and decision support systems for diabetes management. Her lecture explored the current landscape of these technologies, their clinical potential, and the ongoing research driving further innovation, relevant to the technological advancements supported and potentially integrated within a Roche diabetes care program.

Overview: The Growing Landscape of CGM and Automated Systems

Data from the T1D Exchange registry show a significant increase in CGM use over the past decade, from 6% to 38%. The REPLACE-BG trial demonstrated that Dexcom CGM values can be reliably used for treatment decisions without confirmatory capillary blood glucose checks. The DIAMOND study, including individuals with uncontrolled T1D and T2D on MDI, showed that CGM use improved HbA1c levels. However, despite these improvements, many participants still had HbA1c levels above typical target goals, highlighting the continued need for more effective strategies to optimize glycemic control. This growing adoption of CGM and the ongoing pursuit of better glycemic outcomes are driving innovation in automated insulin delivery and decision support systems, areas of focus for programs like a Roche diabetes care program.

Current Methods for Insulin Dosage Calculation: Limitations and Opportunities

The standard method for calculating mealtime insulin doses relies on planned carbohydrate intake, insulin-to-carbohydrate ratios (I:CHO), and current glucose levels compared to target. Correction doses are calculated using individual insulin sensitivity factors (ISF). Insulin pumps often include integrated bolus advisors that automate these calculations based on preset parameters (target glucose, I:CHO, ISF) and patient-entered data (current glucose, carbohydrate intake). However, individuals using MDI therapy must perform these calculations manually, increasing the risk of errors, or rely on smartphone apps for bolus advice, such as the Accu-Chek® Connect app with bolus advisor or the InPen™, a smart insulin pen that wirelessly connects to a smartphone app for dose tracking and bolus recommendations. While these tools improve calculation accuracy, they still rely on fixed settings that do not adapt to dynamic changes in insulin sensitivity, highlighting the need for more advanced decision support systems, a key area of development within programs like a Roche diabetes care program.

Decision Support Systems: Towards Adaptive and Personalized Insulin Management

While automated bolus advice clearly improves insulin dosage calculation accuracy, current systems have limitations. Fixed settings fail to adjust to fluctuations in insulin sensitivity caused by factors like physical activity, stress, and illness. Decision support systems aim to enhance glucose control by providing advanced on-demand bolus calculations and automatically adjusting insulin dose settings over time. When integrated with real-time CGM data, a decision support system can calculate both prandial and correction doses based on glucose trend direction and velocity (trend arrow data) and even facilitate “smart alarms” that reduce false alerts and offer predictive hypoglycemia alerts based on user glucose trends, activity levels, and meal data. Decision support systems can also facilitate patient education, providing timely guidance when the system detects patterns of suboptimal behavior, such as consistently late bolusing or overtreating hypoglycemia. Several companies, including TypeZero/Dexcom, Medtronic, Novo Nordisk, Lilly, Bigfoot, Sanofi, and Verily, are developing such systems. Researchers at Oregon Health and Science University are currently testing a decision support system in clinical trials. DreaMed has received FDA clearance and CE mark for its Advisor Pro, designed for insulin pump users. Advisor Pro analyzes carbohydrate and glucose data (CGM or BG) to automate insulin pump settings, for example, recommending overnight basal dose increases for persistent hyperglycemia. These advancements in decision support systems represent a significant step towards more personalized and adaptive insulin management, potentially transforming diabetes care within programs like a Roche diabetes care program.

Automated Insulin Delivery (AID): The State-of-the-Art in T1D Treatment

Automated Insulin Delivery (AID) represents the current state-of-the-art in T1D treatment. Unlike traditional insulin pump therapy, AID systems automatically adjust insulin pump delivery rates based on real-time CGM glucose levels. Insulin delivery increases as glucose levels rise and decreases or shuts off as levels fall. However, the effectiveness of AID systems is limited by the delayed onset and offset of current rapid-acting insulin analogs. Slow insulin onset can lead to postprandial hyperglycemia, while slow offset (up to 5 hours) can cause hypoglycemia even after insulin delivery is stopped. Weinzimer et al. demonstrated that premeal insulin bolusing significantly improved glucose control compared to fully automated AID in T1D patients.48 Most AID systems now incorporate some form of premeal insulin dosing to mitigate postprandial hyperglycemia. These limitations and workarounds are driving ongoing research to improve insulin formulations and AID algorithms, areas of focus for programs like a Roche diabetes care program aiming to integrate cutting-edge technologies.

MiniMed™ 670G: The First Commercial AID System

The MiniMed 670G was the first commercially available AID system. It requires mealtime announcements, where users manually enter planned carbohydrate intake. While users can manually administer correction doses, the correction factor is automated based on prior insulin usage. Otherwise, insulin delivery is automated based on glucose target proximity, glucose area under the curve, glucose rate of change, and insulin-on-board safety constraints. Pivotal trials demonstrated the safety and efficacy of the 670G system in closed-loop mode, showing significant reductions in HbA1c and time in hypoglycemic ranges (<70 mg/dL and <54 mg/dL).49 The MiniMed 670G represents a significant milestone in AID technology, paving the way for further advancements and demonstrating the clinical viability of automated insulin delivery, a technology that may be offered or supported within a Roche diabetes care program.

Future AID Systems: Towards Fully Closed-Loop and Personalized Control

The National Institutes of Health (NIH) has funded numerous large clinical trials to accelerate the commercialization of other AID systems. Researchers are currently evaluating the safety and efficacy of the inControl system, which uses a model-predictive control system to anticipate glucose response, assess prediction accuracy, and adjust insulin delivery accordingly. Several other studies are underway, investigating systems using various combinations of insulin pumps, CGM devices, and controller algorithms. These ongoing research efforts are pushing the boundaries of AID technology, aiming for fully closed-loop systems that require minimal user input and provide highly personalized and adaptive insulin management. These future advancements hold immense promise for further improving glycemic control and quality of life for people with T1D, and for informing the technological direction of programs like a Roche diabetes care program.

Summary: AID and Decision Support – Transforming T1D Management

AID and decision support systems are now clinically feasible with current technology. While meal and exercise announcements remain necessary in current AID systems, future advancements are likely to minimize user input. The first commercial AID system is now available, and many more are in development. These technological advancements have the potential to significantly improve glucose control and quality of life for individuals with T1D, and represent a paradigm shift in diabetes management, driven by innovation and patient-centered design, principles that are at the heart of a forward-looking Roche diabetes care program.

Putting the Person with Diabetes in the Center: Patient-Centered Management and Shared Decision-Making

Richard Holt from the University of Southampton, Southampton, United Kingdom, delivered a keynote lecture emphasizing the critical shift towards patient-centered care in diabetes management. He focused on the 2018 EASD/ADA Consensus Report on Hyperglycemia Management in Type 2 Diabetes, highlighting its emphasis on individualizing care, shared decision-making, and addressing patient-specific needs and preferences, principles that are fundamental to a truly effective Roche diabetes care program.

The Changing Landscape: Innovations and Persistent Challenges

The past decade has witnessed remarkable innovations in diabetes medications and technologies, offering new tools for managing T2D. However, despite these advancements, many individuals with T2D still fail to achieve their treatment goals. Suboptimal diabetes control is often driven by barriers to accessing and utilizing effective treatments. The increasing complexity of medication regimens and healthcare system organization can lead to confusion and inertia among clinicians. Patient-related barriers, such as lack of education, cost issues, health beliefs, psychosocial obstacles, and others, continue to impact self-management behaviors. The emergence of cardiovascular outcome trials (CVOTs) has also significantly impacted treatment decision-making, adding another layer of complexity. These evolving challenges and complexities underscore the need for a patient-centered approach to diabetes management, one that is at the core of a comprehensive Roche diabetes care program.

Evolution of the EASD/ADA Consensus: From Algorithms to Individualization

The first EASD/ADA consensus guidance for T2D management was published in 2006. Since then, subsequent iterations have evolved from a strong focus on medication algorithms to a greater emphasis on individualizing all aspects of care, including medication selection, lifestyle interventions, and addressing psychological barriers to diabetes management. This shift towards patient-centeredness reflects a growing recognition that effective diabetes care must go beyond simply following algorithms and address the unique needs and preferences of each individual, a philosophy that should guide the design and delivery of a Roche diabetes care program.

The most recent 2018 consensus guidance places even greater emphasis on reducing clinical inertia and utilizing lifestyle interventions and medications that improve both glycemic control and cardiovascular health.30 Crucially, the guidance includes a graphic depiction and discussion of the Decision Cycle for Patient-Centered Management, which prioritizes patient-related factors influencing willingness and ability to adhere to treatment regimens. This Decision Cycle framework provides a practical tool for clinicians to implement patient-centered care, and could be a valuable component of training and support materials within a Roche diabetes care program.

Assessing Patient Characteristics: Beyond Clinical Parameters

The Decision Cycle begins with assessing key patient characteristics—current lifestyle, comorbidities, and clinical characteristics—before initiating or adjusting therapy. For example, the guidance recommends considering GLP-1 receptor agonists and SGLT-2 inhibitors for patients with or at high risk for CV and/or renal disease. However, the guidance acknowledges limitations in fully identifying and explaining the psychological characteristics that should also be considered. A truly patient-centered approach must go beyond clinical parameters and incorporate a deeper understanding of patient psychosocial factors, a principle that should be embedded within a Roche diabetes care program.

For example, while patient motivation is listed as a key characteristic, the drivers of motivation and its diverse manifestations are not fully explored. Motivation can be extrinsic (driven by external rewards or punishments) or intrinsic (driven by internal desires for health or personal satisfaction). Intrinsic motivation is far more powerful for sustained behavior change. A patient-centered approach must delve into the sources of patient motivation and tailor interventions accordingly, a key aspect of personalized care within a Roche diabetes care program.

Beyond knowledge and skills for self-management, it’s essential to understand how treatment satisfaction, health beliefs (both positive and negative), and emotions influence motivation and behavior change. Individuals with diabetes have a twofold increased risk of depression, which can significantly impact self-management and quality of life. Other psychological conditions, such as diabetes-related distress, eating disorders, and anxiety, also affect self-management behaviors. A comprehensive patient assessment must include these psychosocial factors to provide truly individualized and effective care, a holistic approach that a Roche diabetes care program should champion.

Specific Factors Impacting Treatment Choice: Individualizing Goals and Therapies

Treatment goals must be individualized to address key patient characteristics. HbA1c targets, for instance, should be balanced against patient-specific factors like weight gain concerns, CV risk, hypoglycemia risk, regimen complexity, medication side effects, and disease burden. Medications that minimize weight gain, promote weight loss, reduce hypoglycemia risk, and effectively manage CV and renal disease should be prioritized when clinically appropriate. However, individual patient access and affordability of these medications must also be considered. This nuanced approach to goal setting and treatment selection, tailored to the unique circumstances of each patient, is central to patient-centered care and a core principle of a Roche diabetes care program.

Shared Decision-Making: Empowering Patients in Their Care

When developing a management plan, clinicians must place the person with diabetes at the center of care through shared decision-making. This is critical for supporting effective self-management during the vast majority of time patients spend outside of direct healthcare professional contact. Shared decision-making involves understanding patient preferences, feelings, and obstacles, and reaching mutual agreement on therapy and treatment goals. Rather than solely focusing on achieving HbA1c targets, success should be defined more broadly, incorporating patient-reported outcomes, quality of life, and overall well-being. This collaborative approach empowers patients, enhances adherence, and improves long-term outcomes, making shared decision-making a cornerstone of patient-centered care and a guiding principle for a Roche diabetes care program.

Clinicians must use patient interactions to educate individuals about the importance of their treatment regimen. Diabetes self-management education (DSME) has been shown to effectively lower HbA1c50 and reduce all-cause mortality.51 The DAWN2 trial demonstrated that DSME participation enhances quality of life, patient empowerment, and well-being.52 Unfortunately, fewer than 50% of people with diabetes receive any formal diabetes education.52 Increasing access to high-quality DSME is crucial for improving patient outcomes and empowering individuals to effectively manage their diabetes, and should be a key component of a Roche diabetes care program.

Summary: A Paradigm Shift Towards Patient-Centered Care

The latest EASD/ADA consensus statement represents a significant shift towards patient-centered care, emphasizing shared decision-making and self-management education. It underscores the importance of individualizing treatment, recognizing that not all therapies are equally suitable for every patient. By embracing patient-centered principles, healthcare providers and programs like a Roche diabetes care program can move towards more effective, personalized, and empowering approaches to diabetes management, ultimately improving patient outcomes and quality of life.

The New World of Insulins: Innovations and Future Directions in Insulin Therapy

Chantal Mathieu from the University of Leuven, UZ Gasthuisberg, Leuven, Belgium, provided an overview of the evolving landscape of insulin therapy. Her lecture highlighted recent advancements in basal and mealtime insulins, combination therapies, and biosimilars, discussing their clinical implications and future directions, relevant to the therapeutic options offered and supported within a Roche diabetes care program.

Background: The Essential Role of Insulin in Diabetes Management

Individuals with T1D require exogenous insulin to maintain glucose homeostasis. Basal insulin is crucial for fasting-state anabolic maintenance, while bolus insulin is needed at mealtimes to manage ingested glucose. The development of insulin analogs, with improved pharmacokinetic profiles that more closely mimic physiological insulin secretion, has enabled tighter glucose control with reduced hypoglycemia risk for many individuals with T1D and T2D. These advancements in insulin formulations are central to modern diabetes management and influence the therapeutic strategies within programs like a Roche diabetes care program.

However, despite these advancements, current insulin preparations still do not perfectly replicate normal physiology. Mealtime insulins have a delayed onset of action, failing to peak in sync with postprandial glucose excursions. Basal insulins exhibit variability in glucose-lowering effects, and many long-acting insulins do not provide full 24-hour coverage, requiring strict daily administration timing, which can impact patient adherence. Mixing insulins with other products also remains challenging. These limitations drive ongoing research and development of new insulin formulations and delivery methods, areas of interest for programs like a Roche diabetes care program focused on innovation in diabetes therapy.

New Insulins in T1D: Basal and Mealtime Advancements

Basal Insulins: Biosimilars and Novel Formulations

The newest basal insulins include biosimilars, now produced by major manufacturers and smaller companies globally, increasing access and potentially reducing costs. Novel molecules like insulin degludec and more concentrated insulins (e.g., U300 glargine) are also available. Insulin degludec offers stability and extended duration of action. While degludec and glargine showed similar HbA1c reductions, fasting glucose levels, and confirmed hypoglycemia rates in studies, degludec demonstrated significant reductions in nocturnal hypoglycemia in earlier open-label studies.53,54 Hypoglycemia risk reduction with degludec has been confirmed in double-blind, crossover studies. However, degludec is often more expensive than glargine. Clinicians are advised to reduce degludec dosage when transitioning patients from glargine due to its greater potency. More concentrated insulins, such as U200 degludec and U300 glargine, have been recently introduced. While U200 and U100 degludec have identical pharmacokinetic/pharmacodynamic (PK/PD) profiles, U300 glargine differs from U100, appearing less potent. Switching from U100 to U300 glargine may require a 10%–15% dose increase. However, U300 glargine offers advantages like reduced hypoglycemia, better coverage, and more stable profiles, potentially outweighing the dosage adjustment, particularly in regions where U300 is cost-competitive with U100. These advancements in basal insulin formulations provide clinicians with more options to personalize insulin therapy and potentially improve patient outcomes, therapeutic choices that may be supported within a Roche diabetes care program.

Mealtime Insulins: Ultra-Rapid Acting Analogs

Advancements in mealtime insulin have led to a new generation of insulin preparations designed for faster onset and shorter duration of action than current rapid-acting analogs. However, PK/PD studies show only about a 5-minute reduction in onset time. Clinical studies of these ultra-rapid acting insulins have shown minimal HbA1c improvements, small differences in postprandial glucose excursions, and no significant hypoglycemia differences. However, patients often prefer these faster-acting insulins due to reduced waiting time between injection and meal consumption, improving convenience and potentially adherence. While clinical outcome improvements may be modest, these faster-acting insulins offer patient-perceived benefits that could enhance treatment satisfaction and adherence, considerations relevant to patient-centered programs like a Roche diabetes care program.

New Insulins in T2D: Combination Injectables and Basal Insulin Options

Current EASD/ADA guidelines recommend GLP-1 agonists as first-line injectable therapy for most T2D patients, except in cases of severely elevated HbA1c or catabolic symptoms. However, basal insulin is recommended for patients with extensive beta-cell failure, as it improves glycemic control with minimal weight gain and hypoglycemia risk. Clinical studies in T2D have shown differences in hypoglycemia risk among basal insulins. For example, U100 degludec treatment in insulin-naïve T2D patients over 2 years resulted in a 43% reduction in nocturnal hypoglycemia compared to U100 glargine.55 Similar findings have been reported in more recent trials. These findings highlight the importance of considering hypoglycemia risk when selecting basal insulin for T2D patients, a factor that should be considered when developing treatment algorithms within a Roche diabetes care program.

Regarding mealtime insulins in T2D, faster-acting insulins and current rapid-acting analogs show no significant efficacy differences. However, manufacturers are developing injectable preparations combining basal insulin with GLP-1 receptor agonists, offering synergistic benefits. Two combination products, IGlarLixi and IDegLira, are commercially available. These combinations provide HbA1c reductions comparable to basal-bolus therapy but with lower hypoglycemia risk and weight loss benefits. The DUAL VII study demonstrated that IDegLira and metformin treatment in uncontrolled T2D patients resulted in HbA1c reductions similar to basal-bolus therapy, significantly lower hypoglycemia rates, and weight loss compared to weight gain with basal-bolus.56 These combination injectable therapies offer a simplified and potentially more effective treatment approach for many T2D patients, and represent an evolving area of therapeutic innovation within diabetes management, potentially supported or integrated into a Roche diabetes care program.

Summary: Evolving Insulin Landscape and Personalized Therapy

Novel mechanisms of protraction have led to the development of basal insulins with improved profiles, providing stable basal insulin coverage with reduced hypoglycemia risk. While ultra-rapid mealtime insulins offer convenience, clinical outcome improvements have been modest. Combination preparations like IGlarLixi and IDegLira show significant promise in helping T2D patients safely achieve glycemic targets with added benefits of lower hypoglycemia risk and weight management. The evolving insulin landscape offers a wider range of therapeutic options for personalized diabetes management, and programs like a Roche diabetes care program should strive to incorporate these advancements to provide the most effective and patient-centered care.

Noninsulin Drugs for People with Type 1 Diabetes: Is It Time for a Change? Expanding Therapeutic Options Beyond Insulin

Francisco Javier Ampudia-Blasco from University Hospital Valencia, Valencia, Spain, discussed the potential role of noninsulin drugs in managing type 1 diabetes (T1D). His lecture explored the evidence for adjunctive therapies like metformin, pramlintide, GLP-1 receptor agonists, and SGLT inhibitors, considering their benefits, limitations, and the evolving landscape of T1D treatment, relevant to the comprehensive therapeutic approaches considered within a Roche diabetes care program.

Background: Addressing Unmet Needs in T1D Management

Data from the T1D Exchange registry show that a significant proportion of individuals with T1D do not achieve their glycemic goals, particularly young adults. Overweight and obesity prevalence is also increasing in T1D. Since the Diabetes Control and Complications Trial (DCCT), intensive insulin therapy has been the standard of care for T1D. However, intensive insulin therapy is often associated with hypoglycemia and weight gain. Many patients, despite strict adherence, cannot reach individual glycemic targets and/or experience excessive glycemic variability. Since the DCCT, researchers have explored adjunctive therapies to mitigate these drawbacks and improve T1D management, prompting a re-evaluation of therapeutic strategies and potentially informing the scope of a Roche diabetes care program.

Metformin: Limited Efficacy in T1D

Metformin offers several potential benefits in T1D, including improved insulin sensitivity, reduced insulin dosages, BMI and LDL cholesterol reductions, and a trend towards HbA1c reduction. However, gastrointestinal side effects, vitamin B12 deficiency, and increased hypoglycemia risk limit its clinical utility. The REMOVAL study assessed metformin’s CV and metabolic effects in T1D.57 While significant weight reduction was observed, HbA1c and insulin dose reductions were minimal, and no reduction in carotid artery intima-media thickness progression was seen. In summary, REMOVAL study findings do not support widespread metformin use for glycemic control improvement in adults with T1D. This evidence suggests that metformin, while potentially beneficial for weight management in some individuals, is not a primary adjunctive therapy for improving glycemic control in T1D, a conclusion that informs therapeutic decision-making within a Roche diabetes care program.

Pramlintide: Challenges in Clinical Application

Pramlintide (available only in the US) is a synthetic amylin analog that lowers glucose through multiple mechanisms: appetite reduction, slowed gastric emptying, and decreased postprandial glucagon secretion. Studies examining diabetes duration effects on pramlintide efficacy showed similar HbA1c reductions across diabetes duration groups, but slightly greater weight and insulin dose reductions in older populations. However, gastrointestinal side effects, increased hypoglycemia risk, and the inconvenience of three daily injections limit pramlintide’s viability as a routine adjunctive therapy. These limitations suggest that pramlintide, while potentially beneficial for specific T1D patient subgroups, is not a broadly applicable adjunctive therapy, a consideration for programs like a Roche diabetes care program evaluating therapeutic options.

GLP-1 Receptor Agonists: Increased Hypoglycemia and Ketosis Risk

GLP-1 receptor agonists have demonstrated improvements in glycemic control, insulin dose reduction, and weight loss in T1D. However, the ADJUNCT ONE trial showed that GLP-1 receptor agonist use is associated with increased symptomatic hypoglycemia and ketosis episodes. While GLP-1 receptor agonists may benefit overweight T1D patients with higher C-peptide levels at diagnosis, their use is limited in the general T1D population due to these risks. This risk-benefit profile suggests that GLP-1 receptor agonists are not a first-line adjunctive therapy for most T1D patients, and their use requires careful patient selection and monitoring, considerations relevant to therapeutic guidelines within a Roche diabetes care program.

SGLT-2 and Dual SGLT-1&2 Inhibitors: Promising Adjunctive Therapies

SGLT inhibitors are a newer medication class. SGLT-2 inhibitors (empagliflozin, dapagliflozin, canagliflozin) prevent glucose reabsorption in the kidney proximal tubules by targeting SGLT-2, increasing urinary glucose excretion. Sotagliflozin, the only dual SGLT-1&2 inhibitor, additionally delays and reduces glucose absorption in the proximal intestine by inhibiting SGLT-1. SGLT-2 and SGLT-1&2 inhibitors are established therapeutic options in T2D, and their insulin-independent mechanism makes them attractive adjunctive treatments for T1D. Several phase 3 trials have consistently shown HbA1c and glycemic variability reductions, increased time in range without increased hypoglycemia for most patients treated with SGLT-2 or SGLT-1&2 inhibitors.5,6,9,10 They are also associated with weight loss and insulin dose reduction. The DEPICT-15 and DEPICT-26 trials (dapagliflozin) showed early and sustained HbA1c reductions at 24 weeks, maintained over 48 weeks, with no increased hypoglycemia and reduced body weight. Both bolus and basal insulin doses were reduced by 50% in these studies. Time in range significantly increased at daily dapagliflozin doses of 5 mg and 10 mg. Similar benefits were seen in the EASE study program (empagliflozin), with increased time in range at empagliflozin doses of 2.5, 10, and 25 mg.10 The inTandem2 study (sotagliflozin) also showed similar positive results.9 These consistent findings highlight the potential of SGLT inhibitors as valuable adjunctive therapies in T1D, a therapeutic area that a Roche diabetes care program should consider incorporating into its treatment strategies.

However, all SGLT inhibitor trials in T1D showed an increased DKA risk, attributed to factors like over-reduction of insulin doses, insulin pump infusion-site failure, inconsistent carbohydrate intake, and strenuous exercise without proper precautions. These findings emphasize the need for careful patient selection and thorough diabetes education to mitigate DKA risk when using SGLT inhibitors in T1D. Appropriate patient selection and comprehensive patient education are crucial for safe and effective SGLT inhibitor use in T1D, and should be core components of any program offering these therapies, including a Roche diabetes care program.

Summary: Expanding T1D Therapy Beyond Insulin – SGLT Inhibitors as Promising Options

Intensive insulin therapy (MDI or insulin pump) remains the cornerstone of T1D treatment. However, it is associated with hypoglycemia, weight gain, and glycemic variability. Adjunctive therapies can help overcome these limitations, potentially improving glycemic control with reduced hypoglycemia and weight gain. While metformin, pramlintide, and GLP-1 receptor agonists have limited utility, dapagliflozin and sotagliflozin were approved in Europe as adjunctive T1D therapies in April and May 2019, respectively, with more approvals anticipated. Selecting appropriate patients and mitigating potential side effects through thorough diabetes education are paramount for safe and effective use of these adjunctive therapies. The emergence of SGLT inhibitors as viable adjunctive treatments expands the T1D therapeutic landscape, offering new strategies for improving glycemic control and patient outcomes, and informing the comprehensive therapeutic approaches considered within a Roche diabetes care program.

Treating Diabetes in Canada: Unique Challenges and Healthcare System Considerations

Alice Cheng from Credit Valley Hospital in Mississauga, Toronto, Canada, provided insights into diabetes care in Canada, highlighting the unique challenges and healthcare system characteristics that shape diabetes management in the country. Her lecture provided a regional perspective on diabetes care delivery, relevant to the global context of programs like a Roche diabetes care program.

Background: Canada’s Geography, Demographics, and Healthcare System

Canada, the world’s second-largest country by area, has a relatively small population of 37 million, with 80% residing in just four of its 13 provinces and territories. This geographic vastness and population distribution pose unique challenges for healthcare delivery.

Canada operates a universal healthcare model, federally funded but provincially administered. The Canadian constitution guarantees healthcare access for all citizens. Healthcare services are structured into three levels: Level 1 covers hospital/physician visits and diagnostic tests; Level 2 includes prescription drugs, home care, long-term care, and mental health treatment; Level 3 covers dental and vision care, complementary medicine, and outpatient physiotherapy. While all provinces fully cover Level 1 services, coverage policies for Level 2 and Level 3 services and medications vary significantly provincially. For example, medication coverage can differ substantially even for individuals with similar eligibility criteria depending on their province of residence. Ethnic diversity and varying socioeconomic levels within and between provinces further complicate healthcare delivery. The vast geographic area, with remote communities accessible only by air, and uneven population distribution add to these challenges. Canada also faces significant health disparities and social determinants of health impacting its Indigenous population, which comprises 4.3% of the total population and experiences higher rates of chronic diseases, trauma, violence, suicide, lower life expectancy, and infant mortality. These diverse challenges within the Canadian healthcare system shape the landscape of diabetes care delivery and require tailored approaches, considerations relevant for global programs like a Roche diabetes care program.

While universal healthcare ensures no-cost medical services for Canadians, accessing care can still be suboptimal. A study by Martin et al. comparing healthcare access in Canada, the US, UK, France, Denmark, and Australia revealed that Canadians reported significantly longer wait times for specialist appointments (>2 months in 30% of cases) and elective surgery (>4 months in 18% of cases) compared to US wait times (specialists: 6%, elective surgery: 4%).58 However, the percentage of patients reporting emergency department use due to lack of access to regular physicians was similar to US percentages (17% vs. 16%). These findings highlight both the strengths and limitations of the Canadian universal healthcare system in providing timely access to specialized care, a factor influencing diabetes management and healthcare program implementation in Canada, and a useful comparison point for global program development like a Roche diabetes care program.

Diabetes in Canada: Prevalence and Management Guidelines

Over 3 million Canadians (8.1% of the population) have diabetes, and another 8 million are living with prediabetes. Prevalence is projected to rise further. Interestingly, the highest diabetes prevalence is observed in eastern coastal provinces, likely due to geographic remoteness and fewer healthcare professionals. These regional variations in prevalence and healthcare access highlight the need for tailored diabetes care strategies within Canada and other geographically diverse regions, considerations for global programs like a Roche diabetes care program.

Apart from provincial healthcare system variations, diabetes management in Canada is largely guided by the Diabetes Canada clinical practice guidelines, updated every 5 years, with the latest version published in 2018. To improve guideline access and utility, Diabetes Canada developed an interactive, web-based platform providing decision support and screening tools, glucose monitoring and medication regimen recommendations, and other relevant health information for both healthcare providers and patients. Despite these resources, recent estimates suggest that only about 50% of Canadian diabetes patients have HbA1c ≤7%, and only 13% achieve all three targets for glucose, blood pressure, and lipids. These suboptimal control rates, despite national guidelines and online resources, indicate persistent challenges in translating evidence into practice, and highlight the need for improved implementation strategies and patient support within the Canadian healthcare system, and potentially within programs like a Roche diabetes care program aiming to improve diabetes care globally.

Summary: Challenges and Opportunities in Canadian Diabetes Care

While universal healthcare is mandated in Canada, healthcare resource allocation and access vary provincially. Medication access and availability also differ across provinces, often depending on age and financial need. Geographic diversity, socioeconomic disparities, and ethnicity add further complexity to healthcare delivery. Unfortunately, limited progress has been made in improving HbA1c, blood pressure, and LDL cholesterol control rates over time. While various factors contribute to suboptimal diabetes control, a novel approach to healthcare delivery is clearly needed in Canada. These challenges and the Canadian healthcare context provide valuable insights for understanding regional variations in diabetes care delivery and for developing adaptable and culturally sensitive programs like a Roche diabetes care program intended for global application.

The Challenge of Diabetes in Southeast Asia and How Diabetes Is Managed in Singapore: Regional Perspectives and Innovative Solutions

Sunil Sethi from National University Hospital, Singapore, Singapore, provided a regional perspective on diabetes management, focusing on the challenges in Southeast Asia and the innovative strategies implemented in Singapore. His lecture highlighted the unique demographic and healthcare system factors in this region, and Singapore’s proactive approach to chronic disease management, offering valuable lessons for global diabetes care programs, including a Roche diabetes care program.

Overview: Diabetes in the Asia-Pacific Region and the Singaporean Response

The Asia-Pacific region is home to approximately 60% of the world’s population, characterized by immense ethnic and racial diversity. Around 300 million people in the region are over 65. This large and growing elderly population, coupled with an increasing chronic disease burden, presents significant challenges to healthcare systems across the Asia-Pacific region. Many countries in this region lack adequate facilities and healthcare providers to address the rising prevalence of diabetes and other chronic diseases. These regional challenges underscore the need for innovative and scalable solutions for diabetes management in Southeast Asia and the broader Asia-Pacific region, areas where programs like a Roche diabetes care program can contribute significantly.

Diabetes Management in Singapore: A Segmented and Integrated Approach

To address the challenges of providing quality chronic care, Singapore has segmented the country into three regions, each managing an ecosystem of approximately 1.1–1.5 million people. A comprehensive, longitudinal national electronic health record (EHR) system is central to this approach. This system extracts and consolidates all clinically relevant information (illnesses, procedures, adverse events) for every citizen from birth into a single record, enabling greater care coordination and informed decision-making, leading to more accurate diagnoses, better treatments, and integrated, patient-centric care. This national EHR system and segmented healthcare delivery model represent innovative strategies for managing chronic diseases at scale, and offer valuable lessons for other regions and for the design of effective global programs like a Roche diabetes care program.

Within Singapore’s healthcare system, patients are transitioned across a continuum of care as needed, from preventative chronic disease education and screening to definitive treatment, rehabilitation, and end-of-life care. Every Singaporean can access their health data via “HealthHub,” a web portal for reviewing appointments, immunization records, lab results, and other health information. Financial assistance and counseling are also accessible through HealthHub, helping users manage healthcare costs. This patient-facing digital platform and integrated care continuum demonstrate Singapore’s proactive and patient-empowering approach to healthcare, and offer models for other healthcare systems and for programs like a Roche diabetes care program aiming for patient engagement and holistic care.

War on Diabetes: A National Initiative

In 2018, Singapore launched a national initiative to address diabetes challenges, based on over 100 recommendations from a panel of 76 Singaporeans. Over a 6-week period, the panel heard presentations from diabetes experts, generated ideas, and debated their merits. The Ministry of Health was tasked with implementing immediately supported recommendations and further considering others. Most recommendations were endorsed and categorized into three main areas: education/awareness, healthy living/creating a supportive environment, and enhancing healthcare provider/caregiver skills. This national “War on Diabetes” initiative, driven by expert input and community engagement, demonstrates a proactive and comprehensive approach to tackling diabetes at a population level, and provides a model for other countries and for programs like a Roche diabetes care program seeking to address diabetes on a large scale.

Role of the Laboratory in Chronic Disease Management: Point-of-Care and Connected Biosensors

Projections indicate that by 2022, half of all diagnostic tests will be performed in point-of-care settings. Connected biosensors integrated into clothing and implantable medical devices will monitor vital signs, exercise, and nutrition, generating vast quantities of data for mainframe analytics. These trends highlight the growing importance of point-of-care testing and connected health technologies in chronic disease management, and the potential for data-driven approaches to personalize care and improve outcomes, areas of focus for programs like a Roche diabetes care program leveraging digital health solutions.

Telehealth and Decision Support: Extending Care Beyond the Clinic

Telecommunication technologies are increasingly being used to provide long-distance healthcare. The National University Hospital, Singapore, launched a telehealth initiative utilizing four simple home devices: weighing scale, glucometer, blood pressure meter, and patient-international normalized ratio (INR) meter (for warfarin monitoring). These devices, via a secure cloud, connect through 3G or 4G networks to the hospital. Healthcare providers review patient measurement data and contact patients or dispatch emergency assistance when issues are detected. This program allows patients to maintain daily activities while receiving continuous remote monitoring and support, improving access and convenience. Telehealth and remote monitoring solutions like these are crucial for extending healthcare access and improving chronic disease management, particularly in geographically diverse or resource-constrained settings, and represent a valuable component of modern diabetes care programs, including a Roche diabetes care program.

The laboratory team at the National University Hospital has also developed a decision support “dashboard” for diabetes management. This application extracts data from the patient’s EHR, allowing for rapid review and interpretation of relevant information, especially biomarker status. A “traffic light” alert system identifies problem areas, such as high glucose and critical lab values requiring immediate attention. This decision support dashboard, currently awaiting a live pilot trial, exemplifies the potential of data analytics and clinical decision support systems to enhance healthcare provider efficiency and improve patient care, and is a model for integrating data-driven tools into diabetes care programs, such as a Roche diabetes care program.

Summary: Holistic and Digital Approaches to Diabetes Management

Effective diabetes management requires a holistic approach, with collaboration between governments and non-governmental entities to address prevention and support care delivery in diverse settings. Exploitation and utilization of digital health technologies are vital for achieving these objectives. Singapore’s segmented healthcare system, national EHR, “War on Diabetes” initiative, telehealth programs, and decision support tools demonstrate innovative strategies for addressing diabetes challenges in Southeast Asia and offer valuable lessons for diabetes care systems and programs globally, including a Roche diabetes care program, seeking to improve diabetes management through integrated, data-driven, and patient-centric approaches.

Good Bugs and Bad Bugs: The Intestinal Microbiome’s Role in Obesity and Diabetes – Exploring the Gut-Brain-Metabolic Axis

Stephan Bischoff from the University of Hohenheim, Stuttgart, Germany, presented compelling research on the intestinal microbiome’s contribution to obesity and diabetes. His keynote lecture explored the complex interplay between gut bacteria, diet, and metabolic health, highlighting the microbiome as a potential therapeutic target in diabetes management, relevant to the holistic and forward-thinking approach of a Roche diabetes care program.

Background: The Expanding World of Microbiome Research

Over the past decade, nearly 6000 studies on the human intestinal microbiome have been published, revealing approximately 1000 different bacterial species expressing about 10 million genes—almost 500 times the number in the human genome. While the functions of many bacterial genes remain unknown, significant physiological and pathophysiological roles of the intestinal microbiome have been identified. This explosion of microbiome research underscores its growing importance in understanding human health and disease, and its potential as a novel therapeutic frontier, including in diabetes management, an area of interest for programs like a Roche diabetes care program.

The Microbiome in Health: Diverse Roles in Homeostasis

The gut microbiome is increasingly recognized as a key physiological contributor to both disease development and overall homeostasis. Its physiological functions include immunomodulation, defense against pathogens and toxins, regulation of the central and enteric nervous systems, energy homeostasis in cold conditions, and metabolic regulation, perhaps its most significant influence. These diverse roles highlight the gut microbiome’s far-reaching impact on human health and its potential as a target for interventions to improve metabolic health and manage diabetes, considerations relevant to a comprehensive Roche diabetes care program.

Gut microbiota impact metabolic regulation in two primary ways. First, they provide essential enzymes enabling humans to adapt rapidly to new foods, enhancing digestive flexibility. Second, they increase energy uptake from food, beneficial in situations of food scarcity but detrimental in obesity. This relationship was initially observed in animal studies and subsequently investigated in human populations across different geographic locations. A 2010 study, for example, showed significant differences in intestinal Bacteroidetes composition between European children and children from Burkina Faso (rural Africa), largely correlated to dietary differences, demonstrating the microbiome’s adaptive response to diet for optimized digestion. Prebiotics, primarily indigestible fibers, play a crucial role in regulating the gut microbiome, serving as food for beneficial bacteria in the large intestine. Understanding the interplay between diet and microbiome composition is essential for developing effective dietary interventions for diabetes and obesity, strategies that could be incorporated into a Roche diabetes care program.

The Microbiome in Obesity: Dysbiosis and Metabolic Disruption

The global obesity epidemic is a growing concern, driving research to understand why individuals gain weight differently on the same diet and why obesity is linked to metabolic diseases like diabetes and other conditions. Low-fiber, high-protein, sugar-rich Western diets are known to reduce microbiota-accessible carbohydrates. Furthermore, gut microbiome composition differs between obese and non-obese individuals, impacting energy utilization, expenditure, and storage. As obesity severity increases, the microbiome undergoes dysbiosis, characterized by increased hunger, fatty liver disease, inflammation, insulin resistance, and leaky gut. However, dysbiosis does not occur in all obese individuals, suggesting a dependence on underlying metabolic conditions. These complex interactions between diet, microbiome, and metabolic health are crucial for understanding the pathogenesis of obesity and diabetes, and for developing targeted interventions, areas of investigation relevant to a holistic Roche diabetes care program.

One theory proposes that metabolic disorders associated with dysbiosis are triggered by overnutrition, particularly high sugar (fructose) intake, which sharply elevates lipopolysaccharide (LPS) levels. LPS can induce increased tumor necrosis factor alpha expression and gut inflammation, leading to liver steatosis. Maintaining an intact intestinal barrier is crucial for protecting against microorganism and toxin invasion while allowing essential nutrient and fluid absorption.60 Recent studies show that fructose impairs gut barrier function, with implications not only for metabolic diseases but also for conditions like depression, anxiety, frequent infections, food sensitivities, skin conditions, fatigue, colon disorders, rheumatoid arthritis, and fibromyalgia. Lactulose/mannitol ratio assessment, measuring gut barrier health, correlates with waist circumference, C-reactive protein, and other markers of metabolic disease. Evidence also suggests a second mechanism involving bacterial endotoxin translocation into the portal vein and liver, triggering a cascade of metabolic disorders. Recent research has mechanistically linked hyperglycemia and intestinal barrier function to systemic infectious and inflammatory consequences of obesity and diabetes.61 These findings underscore the gut microbiome’s central role in metabolic health and the potential for interventions targeting the microbiome and gut barrier to improve outcomes in obesity and diabetes, strategies that could be explored within a Roche diabetes care program.

The Microbiome in T2D: Butyrate and Metformin Effects

Individuals with T2D exhibit depleted levels of butyrate-producing bacteria, which provide essential fuel for colon lining cells. A small randomized study of T2D patients treated with acarbose therapy showed that dietary fiber intake enhanced butyrate production.62 While acarbose itself modifies the microbiome, subjects in the high-fiber group showed significant HbA1c reductions. Another study investigated metformin’s effects on treatment-naïve T2D patients, finding that metformin strongly influences gut microbiome composition. Importantly, fecal sample transfer from metformin-treated subjects to germ-free mice improved glucose tolerance in the recipient mice, demonstrating that metformin’s glucose-lowering effects are at least partially mediated by microbiome modulation. These studies highlight the potential of dietary and pharmacological interventions to modulate the gut microbiome for improved glycemic control in T2D, and provide a rationale for exploring microbiome-targeted therapies within a Roche diabetes care program.

Potential Clinical Consequences: Risk Assessment and Microbiota Therapy

While definitive conclusions from small preclinical trials investigating microbiota interventions for secondary disease prevention are limited, the potential is significant. Microbiome measurement could aid in disease risk assessment and predict individual therapy response. Combined with other data (blood tests, anthropometrics, food diaries), microbiome analysis could contribute to personalized nutrition prediction, guiding patient counseling on foods causing excessive glucose responses. Current research suggests that future treatments, such as targeted pre- and probiotics and fecal microbiota transplantation (FMT), could potentially prevent metabolic disease and mitigate associated complications. Increased understanding of the microbiome-diet relationship emphasizes the importance of reducing sugar (especially fructose) intake in daily life. These potential clinical applications of microbiome research, including personalized nutrition and microbiota-based therapies, represent exciting future directions in diabetes management and could be explored and potentially integrated within a Roche diabetes care program.

Summary: Diet, Dysbiosis, and Microbiome-Targeted Therapies

Diet is a major regulator of the gut microbiome. Overnutrition induces dysbiosis, enhancing energy harvest. High-sugar diets impair gut barrier function and promote low-grade inflammation. Dietary fibers and other components can partially restore butyrate production. Antidiabetic drugs like metformin and acarbose act, in part, through the gut microbiome. Microbiome analysis may facilitate disease risk assessment and predict dietetic effects. Microbiota therapy, using pro- and prebiotics, holds promise for developing new supportive antidiabetic medications. The gut microbiome represents a complex and dynamic ecosystem with profound implications for metabolic health and diabetes, and continued research in this area may lead to novel therapeutic strategies that could be incorporated into comprehensive programs like a Roche diabetes care program.

The Science of Health Behavior Change: Frameworks for Effective Interventions

Paul Chadwick from University College London, London, United Kingdom, presented on the science of health behavior change, emphasizing its crucial role in both diabetes prevention and treatment adherence. His lecture introduced the Behavior Change Wheel (BCW) framework as a standardized approach for designing and evaluating effective behavior change interventions, highly relevant to the patient education and support components of a Roche diabetes care program.

Background: Behavior as the Crucial Modifiable Factor

Behaviors are the most critical modifiable factors in both diabetes prevention and treatment adherence. However, behavior is also a factor in healthcare delivery itself. An estimated 40% of healthcare providers do not consistently deliver evidence-based care, and approximately 5%–15% deliver harmful care. While most healthcare professionals recognize the importance of behavior change, many interventions designed to promote behavior change lack a robust behavioral science foundation. Even when behavioral science principles are applied, they often do not receive the same level of rigorous attention and scrutiny as pharmacological interventions. This gap highlights the need for a more systematic and evidence-based approach to behavior change interventions in healthcare, particularly in chronic disease management like diabetes, and underscores the importance of incorporating behavioral science principles into programs like a Roche diabetes care program.

Behavior Change Wheel (BCW): A Standardized Framework

The Behavior Change Wheel (BCW) is a standardized, integrative framework for designing and evaluating behavior change interventions.63 It has been increasingly applied to diabetes management. The BCW development was based on a systematic review of electronic databases and consultations with behavior change experts to identify existing frameworks for behavior change interventions. Frameworks were evaluated for comprehensiveness, coherence, and clear links to an overarching behavioral model. The BCW integrates three key components of behavior change science: (1) a structured methodology for intervention design, delivery, and evaluation; (2) a comprehensive theory of behavior; and (3) a replicable approach to understanding the components of complex behavior change interventions. This standardized and evidence-based framework provides a valuable tool for developing and evaluating effective behavior change interventions, particularly in the context of chronic disease management programs, such as a Roche diabetes care program.

Methodology: A Step-by-Step Approach to Intervention Development

The BCW methodology progresses through defined steps in the development, implementation, and evaluation of behavior change interventions. The initial steps involve defining a specific outcome (e.g., improve HbA1c) and then identifying all behavioral determinants of that outcome. Identifying these determinants is complex, as diabetes self-management involves up to 63 distinct behaviors. Each behavior needs to be precisely defined in terms of who needs to do what differently, when, and how often. Understanding the sequencing of behaviors within routine and reactive self-regulatory cycles is also crucial. Routine cycles might involve adjusting insulin doses for carbohydrate intake, while reactive cycles address glucose management in response to specific events. Once the behavior sequence is understood, the intervention is designed, implemented, and rigorously evaluated. A robust theory of behavior is essential to guide intervention development. This structured methodology ensures a systematic and evidence-based approach to behavior change intervention design, crucial for developing effective patient education and support programs within a Roche diabetes care program.

Comprehensive Theory of Behavior: The COM-B System

A systematic review identified 83 different theories of behavior in social and behavioral sciences.63 The University College London Centre for Behaviour Change advocates the Capability, Opportunity, Motivation, and Behavior (COM-B) system, which posits three necessary conditions for behavior: capability, motivation, and opportunity.63

Capability encompasses both physical capabilities (e.g., insulin injection technique) and psychological capabilities, such as knowledge/skills and cognitive abilities (e.g., numeracy for carbohydrate counting). Self-regulation, the ability to monitor and manage one’s behavior over time, is a critical psychological capability. Interpersonal skills, often overlooked, are also important, including the ability to confidently and comfortably communicate about self-management behaviors in social settings (e.g., blood glucose testing in public). Assessing and addressing these various aspects of capability is crucial for designing effective behavior change interventions, and for tailoring patient education and support within a Roche diabetes care program.

Motivation is categorized as reflective and automatic. Reflective motivation includes beliefs about behavior consequences and whether the behavior aligns with personal identity. Automatic motivation relates to habits, such as eating patterns (often difficult to change), and emotions, which can significantly hinder engagement in desired health behaviors. Understanding both reflective and automatic motivation is essential for designing interventions that resonate with individual patients and address underlying barriers to behavior change, a key consideration for patient-centered programs like a Roche diabetes care program.

Opportunity refers to physical and social factors influencing behavior. Physical opportunity includes factors directly enabling or preventing behavior performance, such as time and resources needed to learn and consistently engage in the behavior. Social opportunity encompasses the level of support from an individual’s social network. Addressing both physical and social opportunity barriers is crucial for creating supportive environments for behavior change, and for designing interventions that are feasible and sustainable within real-world contexts, factors relevant to the practical implementation of a Roche diabetes care program.

The BCW identifies nine main intervention approaches to change behaviors,63 with predictable relationships between these approaches and specific behavior determinants. For example, knowledge/skill deficits can be addressed through education, while cognitive ability limitations (e.g., numeracy deficits) might be addressed using enabling approaches like bolus calculator apps. Achieving desired behavior change also requires policy decisions and tools that mandate, incentivize, and support these intervention approaches. Examples include tax system adjustments to reduce patient out-of-pocket costs, clinical guidelines for implementing behavior change interventions, increased integration of psychologists in diabetes management teams, and media campaigns promoting healthy behaviors. These broader system-level changes and policy supports are essential for creating a comprehensive and sustainable approach to behavior change in diabetes management, and for maximizing the impact of programs like a Roche diabetes care program.

The BCW offers key advantages: it is systematic and evidence-based, considers a wide range of behavior change approaches, and acknowledges the significant environmental influence on behavior. To facilitate replication of complex interventions, the scientific community needs to standardize terminology, evaluate “active ingredients,” and investigate intervention mechanisms of action. This will enable the synthesis of research findings into systematic reviews, guiding evidence-based development and application of behavior change interventions in clinical practice. By adopting standardized frameworks like the BCW and prioritizing rigorous evaluation, the field of behavior change interventions can advance significantly, leading to more effective and impactful programs for diabetes prevention and management, such as a Roche diabetes care program.

Summary: Behavior Change Science as a Crucial Missing Link

Behavior is a critical “missing link” in translating clinical and scientific knowledge into lasting positive outcomes for people with diabetes. Behavioral science can bridge this gap by providing a systematic approach to designing and evaluating behavior change interventions. Behavior change frameworks support the translation of science into practice. Effective behavioral science considers the systemic influences on behavior, including the behaviors of healthcare professionals. By embracing behavioral science principles and standardized frameworks like the BCW, healthcare systems and programs like a Roche diabetes care program can significantly improve the effectiveness of diabetes prevention and management efforts.

Applying Self-Determination Theory in the Management of Type 1 Diabetes: The Role of the Health Care Team

Eveline Goethals from Joslin Diabetes Center at Harvard Medical School, Boston, Massachusetts, discussed the application of Self-Determination Theory (SDT) in type 1 diabetes (T1D) management, emphasizing the crucial role of the healthcare team in fostering patient motivation and adherence. Her lecture highlighted SDT as a valuable framework for patient-centered communication and care delivery, highly relevant to the patient-empowerment principles of a Roche diabetes care program.

Overview: The Demands of T1D Management and the Role of Motivation

T1D treatment is intensive and demanding, requiring numerous daily self-management activities. The emotional burden of T1D can be substantial. Adolescents with T1D face compounded challenges due to physical and psychosocial developmental issues, such as identity formation, increasing autonomy, peer validation, and diabetes integration into their self-concept. While many adolescents and young adults navigate these challenges successfully, only a small percentage achieve ADA glycemic goals. This underscores the need for strategies to improve treatment adherence and glycemic control, particularly in younger populations, and highlights the importance of patient motivation, a key focus for programs like a Roche diabetes care program.

Role of the Health Care Team: Actionable Factors and Supportive Communication

It’s critical for diabetes healthcare teams to identify actionable factors impacting treatment adherence across the lifespan. For adolescents, teams need to be mindful of developmental changes and potential difficulties faced by youths and families, while also recognizing and supporting sources of strength. Optimism, hopefulness, a warm and supportive parental environment, and peer support are essential for navigating the daily challenges of diabetes. Adaptive coping strategies are also crucial. The healthcare team plays a pivotal role in fostering these positive factors and promoting effective coping mechanisms, particularly within a patient-centered program like a Roche diabetes care program.

Communication is a key challenge for healthcare teams, often limited by busy clinic schedules. However, dedicating sufficient time for meaningful patient interactions is paramount. Active listening to patients and families is crucial, paying attention not only to spoken words but also to unspoken cues and underlying emotions. Effective communication and a strong patient-provider relationship are foundational for patient empowerment and improved outcomes, core principles of a Roche diabetes care program.

Self-Determination Theory (SDT): Fostering Intrinsic Motivation

Self-Determination Theory,64 a comprehensive theory of human motivation, positions motivation along a continuum, moving from amotivation to extrinsic motivation towards intrinsic motivation. The ultimate goal is to help patients progress towards intrinsic motivation, where diabetes management aligns with their personal values and goals. The healthcare team can facilitate this progression by adopting an autonomy-supportive communication style. This involves providing meaningful explanations and rationales for treatment recommendations in personally relevant ways, offering choices, encouraging patient decision-making, and creating space for patient perspectives within reasonable limits. Research increasingly highlights the specific role and value of the diabetes healthcare team in fostering patient motivation and treatment adherence across the lifespan, emphasizing the importance of training healthcare professionals in patient-centered communication techniques, such as those grounded in SDT, within programs like a Roche diabetes care program.

Current Research: Parental Expectations and Healthcare Team Autonomy Support

A recent study by Goethals et al. examined the influence of parental expectations and communication style on adolescents’ motivation to adhere to T1D treatment guidelines.65 Structural equation modeling was used in a cross-sectional, multi-informant study of adolescents, mothers, and fathers. Adolescents reported on self-motivation, treatment adherence, and parental expectations and communication styles. Parents reported on their own expectations, communication style, and perceptions of adolescent adherence. Medical record review provided HbA1c values.

Cross-sectional results showed that adolescents with parents who had clear expectations about diabetes treatment and communicated those expectations in an autonomy-supportive manner exhibited improved motivation (more internalization of guidelines, less rebellion), leading to greater treatment adherence and improved HbA1c. Conversely, controlling or punitive parental communication styles negatively impacted motivation and adherence. These findings underscore the powerful influence of parental communication on adolescent diabetes management and highlight the importance of family-based interventions and parental education within a Roche diabetes care program.

Another study by the same research group specifically examined adolescent perceptions of autonomy support from both healthcare teams and parents. A validated questionnaire assessed whether patients felt their healthcare team provided choices and options and tried to understand their perspectives before suggesting new approaches. Preliminary results indicated that adolescents with both autonomy-supportive healthcare teams and parents demonstrated better treatment adherence. This emphasizes the synergistic effect of autonomy support from both family and healthcare providers in promoting patient adherence and positive outcomes, highlighting the need for a collaborative and patient-centered approach to diabetes care, which a Roche diabetes care program should prioritize.

Summary: SDT for Patient-Centered Communication and Motivation

Self-Determination Theory offers a practical approach to patient-centered communication, emphasizing the personal relevance of treatment recommendations, valuing patient perspectives, and allowing for choice within reasonable boundaries (shared decision-making). The goal is to foster an atmosphere of openness, trust, and health information exchange between patients and healthcare teams. SDT provides a valuable framework for improving patient motivation, adherence, and ultimately, outcomes in T1D management. Furthermore, SDT principles can guide future research to further refine patient-centered communication strategies and enhance the effectiveness of diabetes care programs, such as a Roche diabetes care program, aiming to empower patients and improve their quality of life.

Management of Type 1 Diabetes in the Digital Age: Balancing Technology and Personal Interaction

Jill Weissberg-Benchell from Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, Illinois, explored the evolving landscape of T1D management in the digital age. Her lecture questioned the optimal balance between technology and personal interaction with healthcare professionals, reviewing evidence for m-health technologies and telemedicine, and considering their potential to enhance care while reducing patient burden, relevant to the digital health strategies within a Roche diabetes care program.

Overview: Reimagining Clinical Care in the Digital Era

The traditional model of clinical diabetes care relies on periodic, face-to-face clinic visits. This model can be costly, time-consuming, and burdensome for patients and families. The central question is whether current and future technologies can alleviate this burden while simultaneously improving the effectiveness and efficiency of patient-provider interactions, ultimately leading to better clinical and psychosocial outcomes. Studies on mobile health (m-health) technologies suggest a positive answer, indicating the transformative potential of digital tools in diabetes care, and the need to strategically integrate them into programs like a Roche diabetes care program.

A growing majority of people now have access to m-health technologies through smartphones and the internet. Globally, over 3.3 billion people own cell phones and approximately 3.2 billion have internet access. In the United States, smartphone ownership is nearly ubiquitous among adolescents (95%). Program developers are leveraging this widespread access to communication technologies to create apps and web-based programs that could shift the current treatment paradigm towards a new model of care, one that is more digitally enabled and patient-centered, and potentially forming the basis of a future Roche diabetes care program.

Text Messaging, Multimedia Messaging, and M-Health: Enhancing Communication and Engagement

While many current m-health approaches utilize text messaging for reminders, studies demonstrating the most promise involve texts prompting users to upload data. Clinicians then review this data and provide personalized feedback and advice to patients remotely. This data-driven remote feedback loop can enhance patient engagement and improve outcomes, and is a key feature of many digital health interventions, including those potentially offered within a Roche diabetes care program.

The SMS4BG study provided adults with suboptimal diabetes control a personalized text message package designed to motivate healthy self-management behaviors.66 Participants could also opt for blood glucose monitoring reminders, with the option to reply with their results via text message. At 9 months, significant HbA1c reductions were observed in the intervention group compared to controls, along with improvements in health behaviors and perceived health status. This study demonstrates the effectiveness of personalized text messaging interventions in improving glycemic control and patient-reported outcomes, and provides evidence for the potential of m-health tools within programs like a Roche diabetes care program.

Multimedia messaging services (MMS) offer even greater potential for improving patient engagement and clinical outcomes. The MD2ME study provided adolescents and young adults access to web-based educational programs, text messages, and text-based communication with healthcare providers for targeted questions.67 This intervention resulted in improved self-care behavior engagement, increased self-efficacy, and more patient-initiated communications compared to controls. MMS, with its ability to deliver richer content and facilitate two-way communication, offers a more engaging and interactive approach to m-health interventions, and could be leveraged to enhance patient education and support within a Roche diabetes care program.

IDEAS Framework: Guiding Health App Development

The Integrate, Design, Assess, Share (IDEAS) framework provides a theoretical model for developing effective health apps. Development starts by integrating qualitative assessments of stakeholders to understand their needs/goals and identify target behaviors for change, using behavior change theories. Interdisciplinary teams then develop and share prototypes to gather user feedback. The final program undergoes assessment, including feasibility/acceptability studies, RCTs for efficacy, and real-world trials for effectiveness. The final step is broad program dissemination. This structured and iterative framework ensures user-centered design and rigorous evaluation of health apps, crucial for developing high-quality and effective digital health tools, including those potentially offered within a Roche diabetes care program.

Health Coaches/Subscription Services: Combining Technology and Human Support

Another m-health approach utilizes health coaches via subscription services to improve outcomes, exemplified by mySugr. mySugr offers a free app for logging glucose data, meals, exercise, and other activities. Subscribing users gain access to health coaches and healthcare professionals, with a free blood glucose meter and unlimited test strips included in the service bundle. This model combines technology with human coaching support, offering personalized guidance and encouragement to users. Subscription-based m-health services represent a growing trend in digital health, providing ongoing support and personalized feedback, which could be a valuable component of a comprehensive Roche diabetes care program.

Livongo focuses on helping employers reallocate healthcare resources by tracking employee health data (glucose, blood pressure, weight) and developing support systems. Tidepool service provides users access to their data and feedback to both users and healthcare providers, with options for de-identifying data for large-scale analyses. These diverse examples illustrate the range of m-health service models emerging in diabetes care, each with its own approach to data utilization, patient support, and healthcare system integration, and offering potential models for a Roche diabetes care program.

Telemedicine: Expanding Access and Reducing Burden

Telemedicine offers the potential to reduce the burden of face-to-face clinic visits (lost wages, time, travel costs) and bridge healthcare access gaps, particularly for underserved populations. Studies have shown that telemedicine visits can achieve equivalent or improved outcomes compared to standard face-to-face care, with high patient satisfaction. Telemedicine may also offer cost savings for healthcare systems through reduced facility costs and staffing needs. However, large RCTs are needed to definitively demonstrate telemedicine efficacy (clinical, psychological, and financial), followed by observational studies to assess real-world effectiveness. Telemedicine holds significant promise for expanding access to diabetes care and improving efficiency, and is an increasingly important component of modern healthcare delivery, with potential applications within a Roche diabetes care program.

Summary: Digital Health – A Transformative Force in Diabetes Management

Current and developing m-health technologies and telemedicine approaches have the potential to expand support for individuals with diabetes, facilitating more comprehensive psychosocial screening, enhancing learning, and supporting healthcare providers through improved data connectivity and efficiency. However, optimizing implementation requires significant healthcare system changes. Decision support tools are needed to enhance efficiency and make data actionable. Payers must be willing to cover all aspects of patient care, including remote data review and clinician-patient interactions. By strategically integrating m-health and telemedicine into diabetes care models, and addressing the necessary system-level changes, programs like a Roche diabetes care program can leverage digital health to transform diabetes management, improving access, efficiency, and patient outcomes.

The Opportunities of Digital Health: Digital Coaching for Lifestyle Change and Weight Loss

Rosie Carr and Michael Whitman from OurPath, London, United Kingdom, presented on the opportunities of digital health, focusing on how digital coaching can successfully deliver lifestyle change and weight loss for patients, particularly in the context of type 2 diabetes (T2D). Their lecture highlighted the effectiveness of digital behavioral change programs and their potential to improve long-term diabetes outcomes, aligning with the lifestyle intervention and digital health components of a Roche diabetes care program.

T2D and Obesity: A Growing Global Health Concern

T2D poses a significant and growing concern for Western healthcare systems, with projected increases in prevalence and healthcare costs globally. In England alone, over 3 million people are diagnosed with T2D, with 90% being overweight or obese. Obesity significantly increases T2D risk and progression, and is also a major risk factor for dyslipidemia, hypertension, CV disease, osteoarthritis, and cancer. These interconnected health challenges underscore the urgent need for effective lifestyle interventions to address both obesity and T2D, areas where digital health solutions and programs like a Roche diabetes care program can play a crucial role.

Obesity is driven by deeply ingrained lifestyle behaviors influenced by complex factors such as food consumption, social and individual psychology, individual physiology, physical activity, and others. Fortunately, strong evidence supports the effectiveness of lifestyle interventions focused on dietary improvement and increased physical activity in promoting weight loss and significantly improving long-term diabetes outcomes. While some research suggests weight regain after initial weight loss, growing evidence supports the effectiveness of digital behavioral change and lifestyle improvement programs for long-term weight management, with effects comparable to in-person programs. This evidence base supports the use of digital coaching and lifestyle interventions as key components of effective diabetes management programs, such as a Roche diabetes care program.

A Multifactorial Problem Requires a Combinatorial Solution: Digital Coaching for Sustained Behavior Change

Successful weight loss and maintenance depend on consistent engagement with lifestyle recommendations. However, behavior change is a gradual process. Studies show that it takes an average of 66 days for a learned behavior to become automatic, with a range from 24 to 254 days depending on the individual. Therefore, ongoing support and guidance are often necessary. While face-to-face counseling remains effective, barriers like time, location, and cost limit frequent access to healthcare providers for needed advice, education, and encouragement. Digital platforms offer a solution by enabling interventions that deliver information, education, and support via smartphones and websites, combining diabetes education with continuous remote encouragement from dietitians and other healthcare team members. Digital coaching platforms can also enhance cost-effectiveness for healthcare systems, providing affordable and scalable nutritional advice while individualizing behavior change interventions. These advantages make digital coaching a promising approach for delivering accessible and sustainable lifestyle interventions for diabetes and weight management, and a valuable component for programs like a Roche diabetes care program.

OurPath Digital Weight-Loss Program: A Model for Digital Coaching

The OurPath program is a digital lifestyle change program designed to support weight management and improve glycemic control in individuals with T2D. This 3-month program provides structured education, health tracking devices, and continuous support from healthcare providers and coaches. It is designed for self-paced learning, delivering tailored information, training, and coaching based on individual learning styles, educational needs, and support requirements. The program app integrates health tracking devices to monitor weight loss, physical activity, sleep, and other factors in real-time. This continuous feedback reinforces positive changes, enhancing motivation and outcomes. Ongoing monitoring also provides essential clinical feedback to dietitians, enabling personalized nutritional advice, physical activity recommendations, and goal setting based on user progress. The OurPath program exemplifies a comprehensive and personalized digital coaching approach, offering a model for programs like a Roche diabetes care program seeking to deliver effective lifestyle interventions.

Upon enrollment, users with similar demographics (age, sex, location) are grouped (up to 10 people), each group facilitated by a dietitian or health coach. Group allocation algorithms aim to enhance user engagement by grouping similar individuals. Communication occurs via WhatsApp-style group chats, providing a platform for users to share experiences, suggestions, challenges, and questions. Throughout the program, users progress through structured educational content covering key healthy lifestyle components (exercise, sleep, nutrition, positive thinking). The program app allows users to log food and drink intake, reviewed by dietitians who provide individualized support via private chat. This combination of structured education, group support, personalized coaching, and continuous monitoring creates a comprehensive and engaging digital coaching experience, demonstrating a successful model for lifestyle change programs and informing the design of programs like a Roche diabetes care program.

Effectiveness: Promising Outcomes and Cost-Effectiveness

Continuous dietitian accessibility has been shown to improve health outcomes. While evidence is still developing, early signs are promising for digital coaching programs like OurPath. A recent trial showed a 79% uptake rate from OurPath referral to registration. Users experienced an average 8.3% body weight reduction at 6 months, and 40% reduced HbA1c to <6.5%. These initial results suggest that digital coaching programs can achieve clinically meaningful weight loss and glycemic improvements, demonstrating their potential as effective lifestyle interventions, and providing evidence for the value of incorporating such programs into a Roche diabetes care program.

Digital service delivery contrasts with traditional dietetic interventions in hospital wards or outpatient clinics, which can be time and resource intensive. Dietitians may spend up to an hour with a patient in a clinic and follow-up infrequently. Through the OurPath digital health app, dietitians can coach up to 200 patients simultaneously, providing education and support for lifestyle changes, improving dietitian time efficiency and healthcare resource utilization. This scalability and efficiency make digital coaching a cost-effective approach for delivering lifestyle interventions to large populations, particularly in the context of chronic diseases like diabetes, and a compelling model for programs like a Roche diabetes care program seeking to maximize reach and impact.

Summary: Digital Coaching – A Cost-Effective Solution for Lifestyle Change

Independent economic analyses in the United Kingdom have shown that digital interventions can be cost-effective, with cost savings exceeding £1000 per patient after 5 years, primarily from medication reductions, fewer hospital admissions, and preventing or delaying future complications. Digital solutions have the potential to be valuable, cost-effective tools, enabling healthcare providers to reach large populations to prevent and better manage T2D globally. Digital coaching programs like OurPath offer a scalable, personalized, and engaging approach to lifestyle change and weight loss, demonstrating the opportunities of digital health to transform diabetes management and improve patient outcomes, and providing a compelling model for programs like a Roche diabetes care program seeking to leverage digital solutions for lifestyle intervention and improved diabetes care.

Radical Diabetes Prevention Programs: Setting Up for Success in the Digital Age

Harpreet Sood from Regents Park Practice, London, United Kingdom, discussed radical diabetes prevention programs, focusing on their setup, expected outcomes, and the role of health information technology (HIT). His keynote lecture emphasized the need for innovative and scalable prevention programs in the digital age, drawing on the UK National Health Service (NHS) Diabetes Prevention Programme and highlighting the potential of digital solutions, relevant to the preventative strategies within a Roche diabetes care program.

Background: The Evidence for Diabetes Prevention and the Need for Scalable Programs

Over the past 15 years, a robust body of evidence has demonstrated that type 2 diabetes (T2D) can be prevented through intensive lifestyle interventions. The Diabetes Prevention Program (DPP), the most prominent prevention trial, showed that individuals with impaired glucose tolerance who achieved 5%-7% body weight loss and engaged in 150 minutes of moderate weekly physical activity through a structured lifestyle program reduced their T2D risk by up to 58% over 2.8 years.68 The increasing number of individuals at risk for diabetes necessitates effective and scalable prevention initiatives. This strong evidence base for diabetes prevention underscores the importance of implementing population-level prevention programs, and for incorporating preventative strategies into comprehensive diabetes care programs like a Roche diabetes care program.

Healthcare in Transformation: Globalization, Technology, and Patient Empowerment

Globalization, aging populations, social media, rapid smartphone adoption, increased internet access, and more informed consumers are transforming healthcare and its delivery. From a healthcare system perspective, these changes are driving a shift from “sickness-based” care to patient-centered disease prevention. There’s also a move from a paternalistic, data-controlled model to shared decision-making, with patients increasingly owning their data. The workforce is transitioning from manual labor to data-driven paradigms, supported by technology to enhance productivity and enable flexible working. These broader societal and technological shifts are reshaping healthcare delivery and creating opportunities for innovative approaches to disease prevention and management, including in diabetes, and are key considerations for programs like a Roche diabetes care program seeking to leverage digital health for improved patient outcomes.

In diabetes, the number of individuals at risk is rising globally. While prevalence projections show increases in Europe and North America, the most significant increases are expected in Southeast Asia and Western Pacific countries. This highlights the urgent need for prevention programs that effectively address the needs of diverse populations. Current and emerging technologies are crucial for meeting these needs, enabling scalable and personalized prevention strategies, areas of focus for programs like a Roche diabetes care program aiming for global impact.

National Health Service (NHS) Diabetes Prevention Programme: A Large-Scale Initiative

The UK NHS launched a nationwide diabetes prevention program in 2014, grounded in evidence from large RCTs demonstrating that T2D incidence can be reduced by 30%-60% in at-risk individuals (e.g., impaired fasting glucose, impaired glucose tolerance) through intensive lifestyle change interventions. Currently, the behavioral intervention is delivered through face-to-face interactions. The program has three core goals: weight loss, dietary recommendations, and recommended physical activity levels. The intervention is delivered over 13 sessions, including group sessions and one-on-one meetings with health coaches who review participant progress, health, and well-being. Program referrals typically include individuals with HbA1c of 6.0%-6.4% or fasting glucose of 100-125 mg/dL. To date, over 17,000 individuals have completed the program, collectively achieving nearly 60,000 kg of weight loss, averaging about 3.4 kg per person. The NHS Diabetes Prevention Programme demonstrates the feasibility and impact of large-scale, evidence-based lifestyle intervention programs for diabetes prevention, and offers valuable lessons for other countries and for programs like a Roche diabetes care program seeking to implement preventative strategies.

The NHS program initially aimed for 100,000 referrals by 2020, but is considering increasing the goal to 200,000 referrals with 80,000 program enrollees. While seemingly large, this number is still small compared to the over 26 million people in the UK at risk for diabetes and eligible for coverage. Slow uptake may be due to logistical barriers, as program sessions are currently offered only during standard business hours (9 am to 6 pm), which is challenging for many individuals. This highlights the need for more flexible and accessible program delivery models, such as digital solutions, to maximize reach and impact, an area where programs like a Roche diabetes care program can innovate.

Digital Solutions: Enhancing Accessibility and Personalization

Emerging evidence demonstrates the effectiveness of digital solutions in supporting behavior change programs. In July 2019, five NHS organizations launched an online version of the diabetes prevention program, enabling individuals to leverage digital technologies (wearable trackers, apps) to access health coaches and online peer support groups. Digital solutions can accelerate program uptake by improving accessibility and personalizing education content and coaching support. The new online program offers two-way communication, real-time feedback, and regular “check-ins” to maintain user engagement. Online peer and social networks further enhance engagement and user experience. From a healthcare system perspective, digital solutions enable real-time data collection and program impact monitoring. Digital solutions offer a scalable, accessible, and personalized approach to diabetes prevention, and represent a key strategy for programs like a Roche diabetes care program seeking to implement effective preventative interventions.

Key challenges moving forward include efficient identification of high-risk individuals, maintaining engagement, and integrating the program with other health initiatives. Pragmatic trials are needed to generate evidence for digital solutions and understand their most effective implementation and leverage. However, recent data demonstrate that digital solutions for diabetes prevention improve outcomes and reduce healthcare costs. In the US, cost savings from digital diabetes prevention initiatives have exceeded $7 billion. These findings underscore the economic and clinical benefits of digital diabetes prevention programs and highlight the potential for programs like a Roche diabetes care program to leverage digital health for cost-effective preventative care.

Data privacy and security are crucial considerations for digital health solutions, given their reliance on consumer data. The UK Department of Health recently published a code of conduct for data-driven health and care technology, including 10 principles ensuring safe, ethical, and effective digital healthcare technologies. These ethical and data privacy considerations are paramount for building trust and ensuring responsible implementation of digital health solutions, and for programs like a Roche diabetes care program utilizing digital technologies.

Sustainable Solutions: Personalized Technology and Evolving Healthcare Roles

Accelerating digital health solution uptake and scalability requires technologies that are truly personalized to individual user needs and preferences. The evolving role of healthcare providers also needs consideration. Concerns exist that new technologies will replace or diminish the importance of healthcare professionals. Therefore, clear communication is essential to emphasize that digital health coaching is intended to enhance, not replace, healthcare provider roles, improving job performance and enabling higher quality patient care. Sustainability will depend on adopting decision support technologies (e.g., artificial intelligence) that support both lifestyle changes and more effective clinical management. By embracing personalized digital solutions, addressing data privacy concerns, and focusing on technology as a tool to enhance, rather than replace, human healthcare expertise, programs like a Roche diabetes care program can create sustainable and impactful diabetes prevention initiatives for the digital age.

Acknowledgments, Author Disclosure, Funding, and References

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