NIH R01 Grant Awarded to Mary Ellen Vajravelu, MD, MSHP, for Novel Clinical Trial in Youth-Onset Type 2 Diabetes Combining CGM, Activity Trackers, and Custom Smartphone Health App Communications
August 29, 2024
Mary Ellen Vajravelu, MD, MSHP, assistant professor of Pediatrics in the Division of Pediatric Endocrinology at UPMC Children's Hospital of Pittsburgh, has been awarded her first National Institutes of Health (NIH)-funded R01 grant.
Dr. Vajravelu’s research project, called "REFLECT2D," is constructed to address the growing challenge of treating type 2 diabetes (T2D) in adolescents and young adults (AYA) through a novel clinical trial combining continuous glucose monitoring with a mobile/smartphone app and an activity tracking device.
The combination of technologies, along with personalized health planning prior to beginning the trial protocol, is designed to allow real-time monitoring of blood-glucose and activity levels and deliver health care prompts and information that may help individuals with their diabetes self-management goals and achieve optimal blood-glucose control.
The Increasing Prevalence of Youth-Onset T2D
T2D is becoming increasingly common among adolescents and young adults and is disproportionately higher in racial and ethnic minorities in the United States. There are many factors at work driving the increased incidence of the disease. Early onset of T2D often leads to severe complications and reduced life expectancy. Managing this condition requires significant lifestyle modifications, including improved nutrition and physical activity, which can present substantial challenges for AYA.
"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. We have to be aggressive with diagnosis, treatment, and helping individuals with self-management in order to achieve good outcomes.”
More About Dr. Vajravelu’s Research Project and Clinical Trial
The REFLECT2D study will enroll 100 AYA participants aged 16 to 24 with T2D. Participants in the study will use the Healthmine mobile app, which integrates continuous glucose monitors (CGMs), activity trackers, and diet logging tools. The Healthmine app provides real-time prompts to encourage health behaviors that can lead to improvements in diabetes self-management.
"The Healthmine app was initially developed for type 1 diabetes by computer scientist Dr. Temiloluwa Prioleau and her team at Dartmouth College. 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.
Before beginning the study, each participant will meet with a certified diabetes educator and dietitian. This initial consultation will help 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 idea is to provide tailored advice rather than a one-size-fits-all approach. Participants will work with a certified diabetes educator and dietitian to set personalized health goals that are realistic and achievable for them," says Dr. Vajravelu.
The study involves a 90-day micro-randomized trial (MRT). During this trial, participants will receive prompts focused on physical activity, nutrition, or no prompt, which will be randomized each day across the cohort. The prompts are tailored to each participant based on their real-time glucose and activity data.
After concluding the MRT, participants will continue to use their CGM for an additional 90-day observational period without receiving any prompts to evaluate the long-term effects of the intervention on glucose control. This phase of the study will help Dr. Vajravelu and her team understand how well participants maintain their diabetes management skills after the prompts are removed.
Dr. Vajravelu's study aims to assess the immediate and sustained impacts of these app-based prompts on blood sugar levels and health behaviors. The goal is to support AYA in developing diabetes self-management skills, ultimately reducing health disparities and improving outcomes for this vulnerable population.
"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."
The study also incorporates community engagement, working with the University of Pittsburgh’s Community Engagement Core to involve community member advisors. These individuals will inform recruitment and retention strategies, ensuring the study addresses the needs and experiences of those affected by T2D.
"We are planning to involve community stakeholders throughout the study. We want to ensure that we address things that matter to the community, focusing on realistic goals for their day-to-day experiences,” says Dr. Vajravelu.
Recruitment for the study will begin in October 2024, targeting both pediatric and adult clinics to achieve a balanced participant pool. The findings from Dr. Vajravelu’s REFLECT2D study may be used to 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.
Further Reading About the Grant and Clinical Trial
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