CGM Academy for Youth With Type 1 Diabetes

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type1 Diabetes
• Intervention / Treatment: Behavioral: CGM Academy

Detailed Description

Youth with type 1 diabetes (T1D) are at increased risk for kidney failure, vision loss, heart disease, and premature mortality due to challenges with glycemic excursions. Continuous glucose monitoring (CGM) systems represent an important advance in diabetes technology with significant advantages over self-monitored blood glucose and the potential to optimize glycemic management. Despite these advances, youth with T1D, including patients at Children's Hospital Los Angeles (CHLA), fail to achieve recommended glycemic targets, highlighting the opportunity for testing innovative diabetes education programs aimed at increased technology uptake such as the CGM Academy intervention.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rosalia Soto; Email: rosoto@chla.usc.edu
• Study Contact Backup: Name: Rebecca Barber, PhD, RN; Phone Number: 11359 (323) 361-1359; Email: rbarber@chla.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Known history of medical adhesive allergies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: CGM Academy; Educational materials as well as online sessions with diabetes educators.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in Hemoglobin A1c from baseline to 6 months	Change in Hemoglobin A1c	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in HbA1c (%) from baseline to 6 months.	Change in Hemoglobin A1c	Baseline to 6 months
Mean change in CGM metrics measured by CGM readings	% Glucose Time in Range (70-180 mg/dL), % Glucose Time Below Range (<70mg/dL), % Glucose Time Above Range (>180mg/dL).	Week 4 & 6 months
Change in perceived diabetes distress at baseline, week 4 & 6 months	The PAIDP is an 18 item survey that measures perceived caregiver burden and has been validated on a geographically diverse sample of caregivers and youth with T1D.	Baseline, Week 4 & 6 months
Change in perceived diabetes family responsibility at baseline, week 4 & 6 months.	The DFRQ is 19-item validated survey assessing parental involvement in various diabetes management tasks	Baseline, week 4 & 6 months
Average number of diabetes educator hours used per study participant at week 4 & 6 months.	Number of hours spent in diabetes education	Week 4 and 6 months

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Rebecca Barber, PhD, RN, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Glycemic Control; Diabetes Education; Type1 Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CHLA-23-00298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No