How Does Diabetes Affect Daily Life? A Beyond-A1C Perspective on Unmet Needs

Discussion

This online survey demonstrates that diabetes has a wide-ranging negative impact on many patients’ lives, extending far beyond the effects on glycemic control and diabetes-related health. Patients experience added stress and vulnerability to stressful life events, time demands, and effects on work or school, future planning, self-confidence, and social interactions. Although diabetes therapies and management technologies have improved dramatically, they are still falling short of addressing the wide-ranging impact of diabetes on quality of life.

It will be crucial for new therapies and technologies to measure and strive to reduce these real-life, day-to-day negative factors, which are arguably just as important as A1C. For example, a therapy that reduces A1C but causes significant hypoglycemia or one that boosts time-in-range blood glucose but is expensive or cumbersome to use would not be ideal. Diabetes invades all aspects of life and therefore should be treated as a holistic condition rather than as merely a disease of poorly regulated glycemia.

Our results also suggest that in an aware and engaged population, the cost of medications, devices, and care remains a major barrier to successful diabetes management. Cost was among the top two most frequently cited barriers for all respondents regardless of the type of diabetes they had (Table 6). Improvements in available treatments and devices will be meaningless unless they are made accessible and affordable. Our data are in line with those found in the work of Tanenbaum et al. (2). Even among the highly engaged T1D Exchange registry participants whom they surveyed, most respondents (57–61%) endorsed cost/insurance coverage as a barrier to device use, far above other barriers.

Our data also suggest that people with type 1 diabetes face challenges that are different from those of people with type 2 diabetes, although there is significant overlap in barriers to management and effects of diabetes on daily life. In our survey, respondents with type 2 diabetes were largely affected by lifestyle modifications such as managing diet, weight, and exercise, whereas those with type 1 diabetes reported more impact from the highs and lows of managing blood glucose, hypoglycemia, and social effects. However, both groups reported serious negative consequences on global aspects of life such as planning for the future, ability to take on life’s challenges, and selfconfidence. Therapies, devices, and tools need to prioritize giving patients their lives back by reducing worry, stress, and time demands and increasing energy, discretion, and the ability to live one’s life. Moreover, we believe that these survey results call for more research into how family members and caregivers can remain supportive of the unmet needs of patients with diabetes.

Limitations of this survey include self-reporting of all data and a nonrepresentative sample of people with diabetes in the United States. Caregivers of children with diabetes (<18 years of age) responded on behalf of their children, and their answers may not have accurately reflected their children’s feelings.

The diaTribe Foundation helped to spearhead the patient-centered “Outcomes Beyond A1C” movement to encourage the FDA and other stakeholders to consider outcome metrics such as time-in-range, hypoglycemia, and patient-reported quality of life in the development, assessment, and labeling of diabetes therapies and devices. The foundation hosted a landmark FDA Center for Drug Evaluation and Research (CDER) workshop titled “Diabetes Outcome Measures Beyond Hemoglobin A1C” on 29 August 2016 and a follow-up meeting on 21 July 2017 titled “Glycemic Outcomes Beyond A1C: Standardization & Implementation.” Both meetings invoked the patients’ perspective and dQ&A survey data to share with FDA information regarding what patients would like their diabetes treatments to achieve. Before these meetings, The diaTribe Foundation presented these data at a 3 November 2014 FDA workshop on “Unmet Needs in Diabetes” and presented on outcomes beyond A1C at a 2012 Drug Information Association gathering.

The device side of the FDA (its Center for Devices and Radiological Health [CDRH]) has recognized the need to consider patients’ perspectives fully, including expanded outcomes beyond A1C (e.g., time-in-range and hypoglycemia). The CDRH review of Medtronic’s MiniMed 670G hybrid closed-loop system is one example of the agency’s willingness to listen to patients. Immediately after the 3-month, single-arm, 670G pivotal trial (designed for safety), more than 80 trial participants wrote to the FDA asking if they could stay on the investigational system while it was under review. The agency granted these users permission and quickly approved the product within an unprecedented timeframe of about 3 months. The CDRH also incorporated input from JDRF and other groups on artificial pancreas guidance and embraced the patients’ perspective in ruling that patients could dose insulin directly from therapeutic CGM. We hope the CDRH’s focus on patients and sense of urgency extends to other devices and also to the drug side of FDA (the CDER). There is still room for drug therapies to improve on measuring outcomes beyond A1C and incorporating such findings into product labels and indications.