Type 2 Continuous Glucose Monitoring Academy

Children's Hospital Los Angeles

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Behavioral: Continuous Glucose Monitoring Academy; Behavioral: Standard Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06516640

CHLA-24-00199

P50MD017344 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 8 to 21 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Receives standard of care, regular education in the clinic.

Treatment:

Behavioral: Standard Education

Continuous Glucose Monitoring Academy

Experimental group

Description:

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.

Treatment:

Behavioral: Standard Education

Behavioral: Continuous Glucose Monitoring Academy