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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06203067
• Other study ID #: 1990806
• Secondary ID: 5438P20GM144270
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 19, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: April 2024
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 106
• Est. completion date: February 28, 2027
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• Standard of Care
Quarterly clinic visits with endocrinology provider.
• 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.

Locations

Country	Name	City	State
United States	Nemours Children's Hospital, Delaware	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Nemours Children's Clinic	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Acceptability	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
Primary	Perceptions of continuous glucose monitoring systems	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.
Primary	Continuous Glucose Monitoring System Use	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
Primary	HbA1c	HbA1c expressed as a percentage of glycosylated hemoglobin	Baseline and 3, 6, 9, and 12 months post-enrollment