Type 1 DiabetesNCT07116434
Discovery Diabetes
A study testing Discovery Program in people with Type 1 Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Discovery Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dina Bu, BS contact
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37240
Abigail Doyle, MSHI, 615-343-6075, abigail.m.doyle@vanderbilt.edu
Shelagh A Mulvaney, PhD
About this study
Official title: Discovery Diabetes: A Pilot Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Discovery Program
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discovery ProgramBehavioural
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:
- Patient-Reported Measures
- In-Clinic Collaborative Goal Setting
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, and 9 months
Secondary outcomes (5)
Change in Diabetes Distress (PAID-T)
This measure will evaluate changes in diabetes distress using the Problem Areas in Diabetes - Teen version (PAID-T) to assess participants' emotional responses related to diabetes management. Each item is scored on a Likert-type scale, from 1 (not a problem) to 6 (serious problem). Scores are summed and then transformed to a 0-100 scale. Minimum value: 0 (no distress), Maximum value: 100 (high distress). Higher scores indicate worse outcomes, meaning more diabetes-related emotional distress.
Measured: Baseline, 3 months, and 6 months
Change in Self-Management Barriers (BDA)
This outcome will assess changes in barriers to diabetes self-management through the Barriers to Adherence Scale (BDA), focusing on factors that may hinder effective diabetes care. The BDA uses a 23-item self-report format where each statement is rated on a 5-point Likert-type scale: 1 = Not at all true and 5 = Completely true. There are 5 distinct subscales which are measured: Stress and Burnout, Time Pressure and Planning, Social Support, Parental Autonomy Support and Stigma. Higher scores reflect greater perceived barriers to diabetes adherence, meaning more challenges experienced by adolescents in managing their condition
Measured: Baseline, 3 months, and 6 months.
Change in Problem-Solving Skills (SPSI-R:SF)
This measure will evaluate changes in problem-solving skills using the Social Problem-Solving Inventory-Revised, Short-Form (SPSI-R:SF, 25-item), which assesses participants' ability to effectively resolve issues related to diabetes management. Each item is scored 0-4 (0 = Not at all true of me; 4 = Extremely true of me). With 25 items, the minimum total score is 0 and the maximum total score is 100. Higher scores on adaptive subscales (Positive Problem Orientation, Rational Problem Solving) = better outcomes. Higher scores on maladaptive subscales (Negative Problem Orientation, Impulsivity/Carelessness Style, Avoidance Style) = worse outcomes. When an overall score is reported, higher values reflect better overall problem-solving ability (maladaptive subscales are reverse-scored for the total).
Measured: Baseline, 3 months, and 6 months.
Change in Diabetes Self-Management Efficacy (SCI-R)
This outcome will assess changes in diabetes self-management efficacy using the Self-Care Inventory-Revised (SCI-R), which measures participants' confidence in managing their diabetes.
Measured: Baseline, 3 months, and 6 months.
Change in Glycemic Control (Time in Range)
This measure will explore changes in the percentage of time participants spend within the target glucose range (TIR) as recorded by Continuous Glucose Monitoring (CGM) devices. Approximately 70% of participants are expected to use CGM devices throughout the study.
Measured: Baseline, 3 months, 6 months, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start14 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shelagh Mulvaney, Vanderbilt University
- Investigators
- Shelagh A Mulvaney, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116434
- Sponsor's protocol ID
- 250525
- Status last verified
- Dec 2025
- First submitted
- 6 Aug 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery Diabetes: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07116434
- Acronym / sponsor ID
- 250525
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Discovery Program | Experimental | Behavioral: Discovery ProgramThis arm will receive the Discovery Program intervention, which includes personalized mobile health communications and clinician support aimed at improving diabetes management. |
| 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. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discovery ProgramThe 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. | Behavioural | Intervention Group: Discovery Program |
Primary outcome
Change in Glycemic Control (HbA1c)
Time frame: Baseline, 3 months, 6 months, and 9 months
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.
5 secondary outcomes
Change in Diabetes Distress (PAID-T)
Time frame: Baseline, 3 months, and 6 months
Change in Self-Management Barriers (BDA)
Time frame: Baseline, 3 months, and 6 months.
Change in Problem-Solving Skills (SPSI-R:SF)
Time frame: Baseline, 3 months, and 6 months.
Change in Diabetes Self-Management Efficacy (SCI-R)
Time frame: Baseline, 3 months, and 6 months.
Change in Glycemic Control (Time in Range)
Time frame: Baseline, 3 months, 6 months, and 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dina Bu, BS contact
Shelagh A Mulvaney, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discovery Program in people with Type 1 Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abigail Doyle, MSHI (615-343-6075, abigail.m.doyle@vanderbilt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycemic Control (HbA1c) (time frame: Baseline, 3 months, 6 months, and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.