Active — Not RecruitingNot Applicable

Type 1 Together: A Peer Mentorship Program to Bolster Use of CGM

United States37 participantsStarted 2024-04-19

Plain-language summary

The goal of this clinical trial is to evaluate a new way of helping adolescents with type 1 diabetes consistently use continuous glucose monitoring systems (CGM). Families who participate will be assigned by chance to one of two groups. One group will continue to see their Endocrinology provider who can give recommendations on ways to use CGM. The other group will be in our Type 1 Together program for 6 months. This will include: 1. Monthly meetings with a community health worker with expertise in type 1 diabetes self-management, 2. Access to CGM-specific educational resources hosted on a mobile app, and 3. Meeting at least monthly with a mentor family who will provide mentorship on using CGM consistently. The main questions the study aims to answer are: 1. Do families like the Type 1 Together program? 2. Do more families in the Type 1 Together program have better attitudes towards CGM, use CGM more consistently, and have lower HbA1c? 3. Does the Type 1 Together program reduce racial and ethnic differences in attitudes towards CGM, consistent use of CGM, and HbA1c?

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 12 to 17 years old * Diagnosed with type 1 diabetes for at least 6 months * Does not use CGM OR uses CGM \< 24 out of the past 30 days * Use CGM 24 to 30 of the past 30 days but most recent HbA1c was 9% or more * Able to read and write in English Exclusion Criteria: * Type 1 diabetes due to other medical condition (e.g., cystic fibrosis) * Intellectual disability * Severe psychiatric comorbidities

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intervention Acceptability

Timeframe: 6 months post-enrollment

Perceptions of continuous glucose monitoring systems

Timeframe: Baseline and 3, 6, 9, and 12 months post-enrollment.

Continuous Glucose Monitoring System Use

Timeframe: Baseline and 3, 6, 9, and 12 months post-enrollment

HbA1c

Timeframe: Baseline and 3, 6, 9, and 12 months post-enrollment

Trial details

NCT IDNCT06203067

SponsorNemours Children's Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

View on ClinicalTrials.gov More Diabetes Mellitus, Type 1 trials

Plain-language summary

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Intervention Acceptability

Timeframe: 6 months post-enrollment

Perceptions of continuous glucose monitoring systems

Timeframe: Baseline and 3, 6, 9, and 12 months post-enrollment.

Continuous Glucose Monitoring System Use

Timeframe: Baseline and 3, 6, 9, and 12 months post-enrollment

HbA1c

Timeframe: Baseline and 3, 6, 9, and 12 months post-enrollment