Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06203067

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

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Hospital, Delaware

Wilmington, Delaware, 19803, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of Care

Behavioral

Quarterly clinic visits with endocrinology provider.

Type 1 Together

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. HbA1c

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

    HbA1c expressed as a percentage of glycosylated hemoglobin

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Type 1 Together: A Peer Mentorship Program to Bolster Use of Continuous Glucose Monitoring Systems Among Adolescents With Type 1 Diabetes

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2024
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.