Discovery Diabetes

NCT07116434 | Recruiting

• 1 other identifier: 250525
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Glycemic Control (HbA1c)

  This outcome measure will assess the change in glycemic control among participants, as indicated by changes in HbA1c levels. The primary aim is to determine whether the Discovery Program leads to significant improvements in glycemic control compared to standard diabetes care.

  Baseline, 3 months, 6 months, and 9 months

Secondary Outcomes (5)

• Change in Diabetes Distress (PAID-T)

  Baseline, 3 months, and 6 months

• Change in Self-Management Barriers (BDA)

  Baseline, 3 months, and 6 months.

• Change in Problem-Solving Skills (SPSI-R:SF)

  Baseline, 3 months, and 6 months.

• Change in Diabetes Self-Management Efficacy (SCI-R)

  Baseline, 3 months, and 6 months.

• Change in Glycemic Control (Time in Range)

  Baseline, 3 months, 6 months, and 9 months

Study Arms (2)

Intervention Group: Discovery Program

EXPERIMENTAL

This arm will receive the Discovery Program intervention, which includes personalized mobile health communications and clinician support aimed at improving diabetes management.

Behavioral: Discovery Program

Control Group: Standard Diabetes Care

NO INTERVENTION

This arm will continue with standard diabetes care practices without the additional psychosocial intervention provided to the intervention group.

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.

Intervention Group: Discovery Program

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37240, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Shelagh A Mulvaney, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Doyle, MSHI

CONTACT

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

Dina Bu, BS

CONTACT

dina.bu@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 11, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)