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Type 1 Together 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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Continuous Glucose Monitoring System Use

HbA1c

Intervention Acceptability

+1 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of General Medical Sciences (NIGMS)NIH

269 Previous Clinical Trials

248,704 Total Patients Enrolled

Nemours Children's ClinicLead Sponsor

124 Previous Clinical Trials

18,025 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria to participate in this medical study?

"To be eligible for participation in this clinical trial, individuals must have a diagnosis of type 1 diabetes and fall within the age range of 12 to 17 years old. The research team aims to enroll approximately 106 patients into the study."

Answered by AI

Are there any available openings for patients to participate in this medical study?

"Based on the information provided by clinicaltrials.gov, this particular study is not currently enrolling patients. The trial was initially posted on March 1st, 2024 and most recently updated on January 2nd, 2024. However, it's worth noting that there are currently 357 other trials actively seeking participants at this time."

Answered by AI

Is the age criterion for participation in this research limited to individuals below 30 years of age?

"To be eligible for participation in this trial, individuals must fall within the age range of 12 to 17. Notably, there are a total of 151 clinical trials available specifically for participants under the age of 18, while there are 169 trials catering to those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Type 1 Together: A Peer Mentorship Program to Increase Equitable Use of Continuous Glucose Monitoring Systems

Paul Enlow 2024. "Type 1 Together: A Peer Mentorship Program to Increase Equitable Use of Continuous Glucose Monitoring Systems". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06203067.

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