Recruiting

Discovery Program

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07116434

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

Interventions

Discovery Program

Study Details

Brief 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.

Conditions

Type 1 Diabetes

Study ID

NCT07116434

Start date

Nov 14, 2025

Status verified date

Dec, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Discovery 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Abigail Doyle, MSHI

615-343-6075abigail.m.doyle@vanderbilt.edu

Dina Bu, BS

dina.bu@vumc.org

Locations

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37240

Contacts

Abigail Doyle, MSHI

615-343-6075abigail.m.doyle@vanderbilt.edu

Principal Investigator:

Shelagh A Mulvaney, PhD

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-12-23.