Type 2 Continuous Glucose Monitoring Academy

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Standard Education; Behavioral: Continuous Glucose Monitoring Academy

• Registration Number: NCT06516640
• Lead Sponsor: Children's Hospital Los Angeles

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-15
• Study Start: 2025-05-01
• Primary Completion: 2025-12-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Current age of 13-24 years;
2. T2D diagnosis;
3. Able to speak, read, and write English or Spanish

Exclusion Criteria

a. Known history of medical adhesive allergies;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard Education	Receives standard of care, regular education in the clinic.
Continuous Glucose Monitoring Academy	Continuous Glucose Monitoring Academy	Receive an interactive workbook with problem-based learning scenarios and video links about CGM 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.
Continuous Glucose Monitoring Academy	Standard Education	Receive an interactive workbook with problem-based learning scenarios and video links about CGM 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.

Primary Outcome Measures

Name	Time	Method
Mean change in Time in Range (TIR) from baseline to 6 months	Baseline to 6 months	Change in % glucose TIR (70-180 mg/dL)

Secondary Outcome Measures

Name	Time	Method
Mean change in Hemoglobin A1c (HbA1c) from baseline to 6 months	Baseline to 6 months	Change in Hemoglobin A1c
Mean change in CGM metrics measured by CGM readings	Week 4 & 6 months	% Glucose Time Below Range (\<70mg/dL), % Glucose Time Above Range (\>180mg/dL), % Glucose Variability (coefficient of variation, CV)
Average number of diabetes educator hours used per study participant at week 4 & 6 months.	Week 4 and 6 months	Number of hours spent in diabetes education
Change in perceived diabetes distress at baseline, week 4 & 6 months	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.
Change in perceived diabetes family responsibility at baseline, week 4 & 6 months	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.

Trial Locations

Locations (1)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States