Discovery Diabetes: A Pilot Randomized Controlled Trial
Vanderbilt University Medical Center
Summary
The goal of this clinical trial is to learn if the Discovery Program can help improve diabetes management in adolescents and young adults with type 1 diabetes (T1D). The main questions it aims to answer are: Does the Discovery Program lead to better glycemic control as measured by HbA1c levels? How does participation in the Discovery Program affect diabetes distress and self-management skills? Researchers will compare participants in the Discovery Program to those receiving standard diabetes care to see if the program has a positive effect on diabetes management. Participants will: Engage in a 3-month intervention that includes personalized mobile health communications and clinician support. Complete surveys and assessments at the beginning of the study, and again at 3 and 6 months. Allow the study team to access their electronic health records for additional data on diabetes management.
Description
The Discovery Diabetes study is a pilot randomized controlled trial designed to evaluate the effectiveness of the Discovery Program in improving diabetes management among adolescents and young adults with type 1 diabetes (T1D). This study focuses on participants aged 13 to 21 who have been diagnosed with T1D for at least one year. Study Design: Participants will be randomly assigned to either the intervention group, which will receive the Discovery Program, or a control group receiving standard diabetes care. The Discovery Program includes personalized mobile health communications, clinician…
Eligibility
- Age range
- 13–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adolescents (13-17 years) and young adults (aged 18-21 years), * Diagnosed with T1D for at least one year, * Access to a smartphone, * A My Health at Vanderbilt (MHAV) patient portal account, * Ability to read, speak, and understand English, * An appointment with an NP in the VUMC Eskind Clinic within 7 months of initial contact Exclusion Criteria: * Diagnosis of type 2 diabetes * Any physical, cognitive, sensory or emotional condition precluding participation in the intervention (seeing/using a phone, hearing digital stories, answering questions).
Interventions
- BehavioralDiscovery Program
The Discovery Program is a novel, hybrid intervention specifically designed to address the psychosocial barriers faced by adolescents and young adults with T1D. This intervention integrates three key components: 1. Patient-Reported Measures 2. In-Clinic Collaborative Goal Setting 3. Personalized Mobile Health Communications The Discovery Program will be delivered over a 3-month intervention period, followed by a 6-month follow-up to assess outcomes. This approach not only aims to improve glycemic control but also seeks to enhance diabetes self-management behaviors, reduce diabetes distress, and build problem-solving skills among participants. The integration of clinical informatics, personalized support, and mobile health technology distinguishes this intervention from traditional diabetes care practices, which often overlook psychosocial factors affecting health outcomes.
Location
- Vanderbilt UniversityNashville, Tennessee