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Peer Mentorship for Type 1 Diabetes

N/A

Waitlist Available

Research Sponsored by Nemours Children's Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

12 to 17 years old

Diagnosed with type 1 diabetes for at least 6 months

Must not have

Type 1 diabetes due to other medical condition (e.g., cystic fibrosis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3, 6, 9, and 12 months post-enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new method to help teenagers with type 1 diabetes use continuous glucose monitoring systems (CGM) consistently. Participants will be randomly assigned to one of two groups. One group will

Who is the study for?

This trial is for adolescents aged 12-17 with type 1 diabetes who haven't been using a continuous glucose monitoring system (CGM) regularly. They should be diagnosed for at least 6 months and able to read/write in English. It's not suitable for those with diabetes due to other conditions, intellectual disabilities, or severe psychiatric issues.

What is being tested?

The study compares standard care from an Endocrinology provider against the 'Type 1 Together' program which includes monthly meetings with health workers, educational resources on a mobile app, and mentorship from experienced families on CGM use over six months.

What are the potential side effects?

There are no direct medical side effects expected from participating in this trial as it involves educational and support interventions rather than medication. However, participants may experience varying levels of engagement or psychological impact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 17 years old.

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I have been diagnosed with type 1 diabetes for over 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have type 1 diabetes caused by another condition like cystic fibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3, 6, 9, and 12 months post-enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3, 6, 9, and 12 months post-enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3, 6, 9, and 12 months post-enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Continuous Glucose Monitoring System Use

HbA1c

Intervention Acceptability

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Type 1 TogetherExperimental Treatment1 Intervention

In Type 1 Together, families will work with other families who have experience using CGM (Peer Mentors) to overcome common barriers to CGM use. Families in the Type 1 Together program will also have access to CGM-specific educational materials, a digital journal to facilitate patient-provider communication around issues with CGM, and social determinant of health screening and intervention with a diabetes community health worker.

Group II: Standard of CareActive Control1 Intervention

Quarterly clinic visits with endocrinology provider.

0 / 3Eligibility criteria met