Randomized Control Trial Evaluating the Impact of CGM Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 1 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Children's Hospital Los Angeles
RECRUITING
Los Angeles
Contact Information
Primary
Rebecca Barber, PhD, RN
rbarber@chla.usc.edu
(323) 361-1359
Backup
Natalia Garban
ngarban@chla.usc.edu
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 90
Treatments
Experimental: CGM Academy
* 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.
No_intervention: Standard Diabetes Education
* receive standard education provided to all patients at CHLA~* complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Los Angeles

This content was sourced from clinicaltrials.gov