A Scalable and Effective Digital Behavioral Intervention for Mitigating Hypoglycemia among People with Diabetes: An Optimization Trial

About This Grant

Project Summary Level 2 hypoglycemia (i.e., low blood glucose) can affect one’s daily life; generate fear and psychological distress; and lead to brain dysfunction, heart complications, and even death. People living with type 1 diabetes (T1D) are particularly susceptible to developing Level 2 hypoglycemia due to the obligatory use of exogenous insulin to manage diabetes. Advanced diabetes technologies (ADTs), such as continuous glucose monitoring and closed- loop insulin pumps, have become the standard of care to improve diabetes control and reduce hypoglycemia. Yet roughly one in three adults living with diabetes continue to develop Level 2 hypoglycemia despite using ADTs, and no strategies have demonstrated effectiveness in alleviating hypoglycemia beyond these standard-of-care technologies. Training to improve hypoglycemia symptom detection and psychoeducation for addressing unhelpful hypoglycemia beliefs have shown promise in reducing Level 2 hypoglycemia. However, these approaches’ effectiveness requires confirmation in ADT users. A scalable intervention with low patient burden is especially needed to expand access to these strategies. We have developed and feasibility-tested two automated real-time patient glucose data–guided digital intervention components delivered via SMS messages: digital hypoglycemia symptom detection training and digital hypoglycemia psychoeducation. In the proposed project, we will conduct a clinical trial to determine the individual and combined contributions of these two components to reducing Level 2 hypoglycemia in T1D adults who continue to develop Level 2 hypoglycemia despite using ADTs. We will then select the intervention that best balances effectiveness with recipient burden as the optimized program for future implementation. We will recruit 208 participants across the U.S. to achieve this objective. Under a 2×2 factorial design, participants will be randomly assigned to one of four experimental conditions: (1) digital hypoglycemia symptom detection training; (2) digital hypoglycemia psychoeducation; (3) both; or (4) usual care only; all participants will be followed up for 1 year. We will determine the individual and combined effects of the digital hypoglycemia symptom detection training and hypoglycemia psychoeducation on reducing Level 2 hypoglycemia (Aim 1). Then, we will identify and select the intervention that best balances effectiveness with recipient burden as the final program (Aim 2). Finally, we will investigate the intervention mechanisms of action and explore potential factors moderating the intervention effectiveness (Aim 3) based on our trial and qualitative interview data. We hypothesize that each digital component (i.e., hypoglycemia symptom detection training and hypoglycemia psychoeducation) will have an effect in reducing Level 2 hypoglycemia in adult ADT users. By the end of this study, we will (1) inform the strategies necessary to address Level 2 hypoglycemia beyond the current standard of care and (2) provide an effective, scalable solution to alleviate this devastating and even life-threatening complication.