Type 2 Continuous Glucose Monitoring Academy

NCT06516640 — Not applicable, Recruiting, 60 participants, Children's Hospital Los Angeles

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT06516640
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	60 (Estimated)
Sponsor	Children's Hospital Los Angeles (Other); collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Conditions	Type 2 Diabetes
Interventions	Continuous Glucose Monitoring Academy, Standard Education (Behavioral)
Dates	start 2025-06-23, primary completion 2026-09-01 (estimated), completion 2026-12-30 (estimated), first posted 2024-07-24, last updated 2026-02-06
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Control	Placebo comparator	Behavioral: Standard Education	Receives standard of care, regular education in the clinic.
Continuous Glucose Monitoring Academy	Experimental	Behavioral: Continuous Glucose Monitoring Academy; Behavioral: Standard Education	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.

Continuous Glucose Monitoring Academy (Behavioral): Educational materials as well as online sessions with diabetes educators.
Standard Education (Behavioral), also known as Standard of Care: Standard of care receives general education about diabetes.

+Outcome measures

Primary outcomes

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 outcomes

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)
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.
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
Mean change in perceived benefits of Continuous Glucose (CGM) Monitor use [Week 4 & 6 months]: 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.
Mean change in perceived burden of Continuous Glucose Monitor (CGM) use [Week 4 & 6 months]: 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.

+Eligibility

Sex: All, ages: 8 Years to 21 Years

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;

+Locations (1)

Facility	City	Country	Status
Children's Hospital Los Angeles	Los Angeles, California	United States	Recruiting

+Investigators

Rebecca Barber, PhD, RN, Principal investigator, Children's Hospital Los Angeles

+Funding

NIH grants: P50MD017344

My Notes

Public

To Read Reading Read