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

NCT06203067 | Active Not Recruiting

• 3 other identifiers: 1990806P20GM1442705438
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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. 1.Monthly meetings with a community health worker with expertise in type 1 diabetes self-management,
2. 2.Access to CGM-specific educational resources hosted on a mobile app, and
3. 3.Meeting at least monthly with a mentor family who will provide mentorship on using CGM consistently.
4. 4.Do families like the Type 1 Together program?
5. 5.Do more families in the Type 1 Together program have better attitudes towards CGM, use CGM more consistently, and have lower HbA1c?
6. 6.Does the Type 1 Together program reduce racial and ethnic differences in attitudes towards CGM, consistent use of CGM, and HbA1c?

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (4)

• 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

• 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.

• 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

• HbA1c

  HbA1c expressed as a percentage of glycosylated hemoglobin

  Baseline and 3, 6, 9, and 12 months post-enrollment

Study Arms (2)

Type 1 Together

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

Quarterly clinic visits with endocrinology provider.

Behavioral: Standard of Care

Interventions

Standard of Care BEHAVIORAL

Quarterly clinic visits with endocrinology provider.

Standard of Care

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.

Type 1 Together

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Type 1 diabetes due to other medical condition (e.g., cystic fibrosis)
• Intellectual disability
• Severe psychiatric comorbidities

Sponsors & Collaborators

• National Institute of General Medical Sciences (NIGMS): collaborator
• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Hospital, Delaware

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: April 19, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)