CompletedNot Applicable

Type 1 Diabetes Education and Support Study

United States43 participantsStarted 2023-04-15

Plain-language summary

Diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens Black patients ages 18-30 years with type 1 diabetes (T1D). In order to combat this issue, this study assesses the feasibility of the culturally tailored intervention T1DES and evaluates the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among Black young adults with T1D.

Who can participate

Age range

18 Years – 30 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: * Kaiser Permanente Georgia Member * Aged 18 - 30 years * Confirmed diagnosis of Type 1 diabetes * Hemoglobin A1c \> 7.5 at time of enrollment * a cell phone able to send/receive text messages * Self-reported race of Black or African American * Ability to read in English and provide informed consent Exclusion Criteria: * Developmental delay or other cognitive impairment that would render the participant unable to provide informed consent * Subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions * Diabetes complications that would preclude participation in the study

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

Diabetes Distress

Timeframe: 3 months

Diabetes Distress

Timeframe: 6 months

Diabetes Distress

Timeframe: 3 months

Diabetes Distress

Timeframe: 6 months

A1C

Timeframe: 3 months

A1C

Timeframe: 6months

Trial details

NCT IDNCT05735340

SponsorKaiser Permanente

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-06

View on ClinicalTrials.gov More Type1diabetes trials

Plain-language summary

Who can participate

Age range

18 Years – 30 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.