Vanderbilt Clinical Trials

Discovery Diabetes

Purpose

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.

Condition

Type 1 Diabetes

Eligibility

Eligible Ages: Between 13 Years and 21 Years
Eligible Sex: All
Accepts 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).

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.	Behavioral: 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.
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.

Recruiting Locations

Vanderbilt University
Nashville 4644585, Tennessee 4662168 37240

Contact:
Abigail Doyle, MSHI
615-343-6075
abigail.m.doyle@vanderbilt.edu

More Details

Status: Recruiting
Sponsor: Vanderbilt University Medical Center

Study Contact

Abigail Doyle, MSHI
615-343-6075
abigail.m.doyle@vanderbilt.edu

Detailed 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 support, and structured problem-solving sessions aimed at addressing psychosocial barriers to effective diabetes management. Objectives: The primary objective is to determine whether the Discovery Program leads to significant improvements in glycemic control, measured by changes in HbA1c levels over a 6-month period. Secondary objectives include assessing the impact on diabetes distress, self-management behaviors, and participants' problem-solving skills. Data Collection: Data will be collected at baseline, 3 months, and 6 months, utilizing a variety of methods, including surveys and electronic health records (EHR). The study will ensure participant confidentiality through the use of unique study IDs and secure, HIPAA-compliant data storage systems, such as REDCap. Eligibility Criteria: Eligible participants include those aged 13-21 with a diagnosis of type 1 diabetes, while individuals with type 2 diabetes or other conditions that may hinder participation will be excluded. Retention and Use of Data: All collected data will be retained for at least six years post-study completion, in compliance with institutional and regulatory requirements. De-identified data may be used for research publications or presentations, ensuring participant privacy is maintained throughout the study. This trial aims to provide valuable insights into improving diabetes management strategies for young individuals facing unique challenges in their care.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.