Type 2 Continuous Glucose Monitoring Academy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Glucose Monitoring Academy, Standard Education.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 8 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Behavioral Continuous Glucose Monitoring Academy
Educational materials as well as online sessions with diabetes educators. - Behavioral Standard Education
Standard of care receives general education about diabetes.
Primary outcome measures
- Mean change in Time in Range (TIR) from baseline to 6 months [Time frame: Baseline to 6 months]
Secondary outcome measures (7)
- Mean change in Hemoglobin A1c (HbA1c) from baseline to 6 months [Time frame: Baseline to 6 months]
- Mean change in CGM metrics measured by CGM readings [Time frame: Week 4 & 6 months]
- Change in perceived diabetes distress at baseline, week 4 & 6 months [Time frame: Baseline, Week 4 & 6 months]
- Change in perceived diabetes family responsibility at baseline, week 4 & 6 months [Time frame: Baseline, week 4 & 6 months]
- Average number of diabetes educator hours used per study participant at week 4 & 6 months. [Time frame: Week 4 and 6 months]
- Mean change in perceived benefits of Continuous Glucose (CGM) Monitor use [Time frame: Week 4 & 6 months]
- Mean change in perceived burden of Continuous Glucose Monitor (CGM) use [Time frame: Week 4 & 6 months]
Eligibility criteria
Inclusion criteria
- Current age of 8-21 years;
- T2D diagnosis;
- Able to speak, read, and write English or Spanish
Exclusion criteria
a. Known history of medical adhesive allergies;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Children's Hospital Los Angeles — Los Angeles
Identifiers
NCT: NCT06516640 · CHLA-24-00199 · P50MD017344