A novel clinical trial, REFLECT2D, is set to explore a new approach to managing youth-onset type 2 diabetes (T2D) by integrating continuous glucose monitoring (CGM) with a smartphone application and activity tracking devices. Funded by a National Institutes of Health (NIH) R01 grant awarded to Dr. Mary Ellen Vajravelu at UPMC Children's Hospital of Pittsburgh, the study aims to provide real-time monitoring and personalized health interventions to adolescents and young adults (AYA) struggling with T2D.
Addressing the Growing Challenge of Youth-Onset T2D
Type 2 diabetes is increasingly prevalent among adolescents and young adults in the United States, with disproportionately higher rates in racial and ethnic minorities. Early onset of T2D can lead to severe complications and reduced life expectancy, making effective management crucial. "Youth-onset type 2 diabetes has become a priority for a number of groups, including the NIH and the American Diabetes Association," says Dr. Vajravelu. "It’s important that all providers recognize this growing problem because we know from the existing data that early-onset T2D progresses quickly and can lead to severe negative outcomes for individuals."
The REFLECT2D Study: A Technology-Driven Approach
The REFLECT2D study will enroll 100 AYA participants aged 16 to 24 with T2D. Participants will use the Healthmine mobile app, which integrates CGMs, activity trackers, and diet logging tools. The app provides real-time prompts to encourage health behaviors that can lead to improvements in diabetes self-management. The study involves a 90-day micro-randomized trial (MRT), during which participants will receive prompts focused on physical activity, nutrition, or no prompt, randomized daily. These prompts are tailored based on real-time glucose and activity data.
"The Healthmine app was initially developed for type 1 diabetes... We are now adapting it for type 2 diabetes in a younger population, integrating features like micro-randomized prompts to see if tailored interventions can make a difference in blood sugar control," says Dr. Vajravelu.
Personalized Health Planning and Community Engagement
Prior to the trial, each participant will meet with a certified diabetes educator and dietitian to set personalized health goals, including dietary recommendations and physical activity targets. Participants will also undergo a baseline assessment using CGMs to evaluate their initial glycemic control over a 10-day period. The study also incorporates community engagement, working with the University of Pittsburgh’s Community Engagement Core to involve community member advisors, ensuring the study addresses the needs and experiences of those affected by T2D.
Evaluating Long-Term Effects and Scalability
After the MRT, participants will continue using their CGM for an additional 90-day observational period without prompts to evaluate the long-term effects of the intervention on glucose control. Recruitment for the study will begin in October 2024, targeting both pediatric and adult clinics. The findings from the REFLECT2D study may inform the development of scalable interventions that can be implemented widely, addressing barriers to in-person care and enhancing health equity for youth with T2D. "By providing timely and relevant feedback, we hope to empower adolescents and young adults to take control of their health and improve their quality of life," Dr. Vajravelu added.
