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

April 22, 2024 updated by: Paul Enlow, Nemours Children's Clinic

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?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours Children's Hospital, Delaware

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Type 1 Together
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.
Behavioral: Type 1 Together
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.
Active Comparator: Standard of Care
Quarterly clinic visits with endocrinology provider.
Behavioral: Standard of Care
Quarterly clinic visits with endocrinology provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous Glucose Monitoring System Use
Time Frame: Baseline and 3, 6, 9, and 12 months post-enrollment
The number of days a patient wore their continuous glucose monitoring system at least 12 hours over the past month.
Baseline and 3, 6, 9, and 12 months post-enrollment
HbA1c
Time Frame: Baseline and 3, 6, 9, and 12 months post-enrollment
HbA1c expressed as a percentage of glycosylated hemoglobin
Baseline and 3, 6, 9, and 12 months post-enrollment
Intervention Acceptability
Time Frame: 6 months post-enrollment
How acceptable youth and caregivers find Type 1 Together. This information will be collected only from participants in the experimental arm using the Acceptability of Intervention Measure (scores range 1-5 with higher scores indicating greater acceptability).
6 months post-enrollment
Perceptions of continuous glucose monitoring systems
Time Frame: Baseline and 3, 6, 9, and 12 months post-enrollment.
Youth perceptions of the benefits and burdens of using continuous glucose monitoring systems will be assessed using the CGM Benefits and Burdens Scales (scores range 1-5 with higher scores indicating greater perceived benefits or burdens).
Baseline and 3, 6, 9, and 12 months post-enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Collaborators

National Institute of General Medical Sciences (NIGMS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1990806
  • 5438 (Other Identifier: NIGMS Sub-Project ID)
  • P20GM144270 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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