Discovery Diabetes

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07116434
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
13 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Discovery Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Nov 14, 2025
Status verified
Dec 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention Group: Discovery Program
    This arm will receive the Discovery Program intervention, which includes personalized mobile health communications and clinician support aimed at improving diabetes management.
  • No Intervention: Control Group: Standard Diabetes Care
    This arm will continue with standard diabetes care practices without the additional psychosocial intervention provided to the intervention group.

Primary Outcome Measure

Change in Glycemic Control (HbA1c) [ Time Frame: Baseline, 3 months, 6 months, and 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt UniversityNashvilleTennessee37240
Abigail Doyle, MSHI
[email protected]
615-343-6075
Shelagh A Mulvaney, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Vanderbilt University· Nashville, TN

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