Type 2 Continuous Glucose Monitoring Academy

Randomized Control Trial Evaluating the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes

The goal of this clinical trial is to evaluate the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes (T2D):

• The first aim is to determine how feasible it is to adapt the Continuous Glucose Monitoring Academy curriculum to teach youth with T2D glucose management strategies.
• The second aim is to evaluate the effects of the Continuous Glucose Monitoring Academy metrics.
• The third aim is to explore the relationships between these metrics with diabetes distress, diabetes family responsibilities, and process metrics.

Participants will join for a total of four weeks of education, followed by a six-month clinical review. They will have access to an online workbook and videos, and will participate in virtual sessions with a diabetes educator who will cover glucose management strategies in-depth. Participants will wear their preferred Continuous Glucose Monitoring system (Dexcom or FreeStyle Libre) provided via insurance and inserted at the baseline visit.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Standard Education; Behavioral: Continuous Glucose Monitoring Academy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Barber; Phone Number: 3233611359; Email: rbarber@chla.usc.edu
• Study Contact Backup: Name: Natalia Garban; Phone Number: 3233611359; Email: ngarban@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children's Hospital Los Angeles
      • Contact: Natalia Garban; Email: ngarban@chla.usc.edu
      • Principal Investigator: Rebecca Barber, PhD, RN

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Current age of 8-21 years;
2. T2D diagnosis;
3. Able to speak, read, and write English or Spanish

Exclusion Criteria:

a. 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
Placebo Comparator: Control; Receives standard of care, regular education in the clinic.	Behavioral: Standard Education; Standard of care receives general education about diabetes.; Other Names: Standard of Care
Experimental: Continuous Glucose Monitoring Academy; Receive an interactive workbook with problem-based learning scenarios and video links about Continuous Glucose Monitoring and glucose management strategies (CGM Academy Program). 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: Standard Education; Standard of care receives general education about diabetes.; Other Names: Standard of Care; Behavioral: Continuous Glucose Monitoring Academy; Educational materials as well as online sessions with diabetes educators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in Time in Range (TIR) from baseline to 6 months	Change in % glucose TIR (70-180 mg/dL)	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mean change in Hemoglobin A1c (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 Below Range (<70mg/dL), % Glucose Time Above Range (>180mg/dL), % Glucose Variability (coefficient of variation, CV)	Week 4 & 6 months
Change in perceived diabetes distress at baseline, week 4 & 6 months	The Type 2 Diabetes Distress Assessment System (T2-DDAS) measures how much overall emotional distress is due to diabetes. Respondents are given statements about diabetes-related issues and indicate on a 5-point Likert scale (0 = not a problem, 1 = minor problem, 2 = moderate problem, 3 = somewhat serious problem, 4 = serious problem) the degree to which the statements are a problem. Increasing scores denote increased burden perceived.	Baseline, Week 4 & 6 months
Change in perceived diabetes family responsibility at baseline, week 4 & 6 months	The Diabetes Family Responsibility Questionnaire (DFRQ) is a 14-item validated survey assessing parental and child involvement in various diabetes management tasks. Youth and caregivers report on a 3-point scale (1=child, 2=equal, 3=parent) who is responsible for a given diabetes task. Higher scores indicate more parental involvement in diabetes management.	Baseline, week 4 & 6 months
Mean change in perceived benefits of Continuous Glucose (CGM) Monitor use	Name of questionnaire: Adolescent Benefits and Burdens of CGM Survey - BenCGM & BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree.	Week 4 & 6 months
Mean change in perceived burden of Continuous Glucose Monitor (CGM) use	Name of questionnaire: Adolescent Benefits and Burdens of CGM Survey - BenCGM & BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree.	Week 4 & 6 months

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Rebecca Barber, PhD, RN, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Type 2 Diabetes; Glycemic Control; Diabetes Education
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: CHLA-24-00199; P50MD017344 (U.S. NIH Grant/Contract)

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
• product manufactured in and exported from the U.S.: No