CGM Academy for Youth With Type 1 Diabetes

NCT06408207 | Recruiting

• 1 other identifier: CHLA-23-00298
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to compare the effects of a virtual education curriculum in blood glucose variation of youth with type 1 diabetes wearing continuous glucose monitoring (CGM) device. The main questions the study aims to answer are:

• Do participants undertaking the proposed curriculum present improved glucose variation than participants of standard education?
• Explore relationships between participant's glycemic outcomes with diabetes distress, diabetes family responsibilities, and number of hours of diabetes education. Participants in the intervention group will:
• receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies.
• participate in four in-depth online group sessions with diabetes care and education specialists
• complete questionnaires three times: at the time of study enrollment, week 4 and 6 months. Participants in the comparison group will:
• receive standard education provided to all patients at CHLA
• complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.

Conditions

Type1 Diabetes

Keywords

Continuous Glucose Monitoring; Glycemic Control; Diabetes Education; Type1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean change in Hemoglobin A1c from baseline to 6 months

  Change in Hemoglobin A1c

  Baseline to 6 months

Secondary Outcomes (7)

• Mean change in HbA1c (%) from baseline to 6 months.

  Baseline to 6 months

• Mean change in CGM metrics measured by CGM readings

  Week 4 & 6 months

• Change in perceived diabetes distress at baseline, week 4 & 6 months

  Baseline, Week 4 & 6 months

• Change in perceived diabetes family responsibility at baseline, week 4 & 6 months.

  Baseline, week 4 & 6 months

• Average number of diabetes educator hours used per study participant at week 4 & 6 months.

  Week 4 and 6 months

Study Arms (2)

CGM Academy

EXPERIMENTAL

* receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies. * participate in four in-depth online group sessions with diabetes care and education specialists * complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.

Behavioral: CGM Academy

Standard Diabetes Education

NO INTERVENTION

* receive standard education provided to all patients at CHLA * complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.

Interventions

CGM Academy BEHAVIORAL

Educational materials as well as online sessions with diabetes educators.

CGM Academy

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Current age of 8-18 years, age group eligible for CGM therapy with Dexcom G6 and G7
• T1D duration ≥6 months, as insulin adjustments during honeymoon stage differs from establishedT1D
• Able to speak, read, and write English or Spanish
• Smartphone compatible with Dexcom G6 and G7application
• Ability to participate in virtual visits

You may not qualify if:

• Known history of medical adhesive allergies

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Study Officials

• Rebecca Barber, PhD, RN

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Barber, PhD, RN

CONTACT

(323) 361-1359; rbarber@chla.usc.edu

Natalia Garban

CONTACT

ngarban@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Everyone will know their assigned intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Simple randomization

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: May 10, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 6, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)