Randomized Control Trial Evaluating the Impact of CGM Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 1 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Mean change in Hemoglobin A1c from baseline to 6 months
Study Overview
Brief Summary
The goal of this randomized clinical trial is to compare the effects of a virtual education curriculum in blood glucose variation of youth with type 1 diabetes wearing continuous glucose monitoring (CGM) device. The main questions the study aims to answer are:
- Do participants undertaking the proposed curriculum present improved glucose variation than participants of standard education?
- Explore relationships between participant's glycemic outcomes with diabetes distress, diabetes family responsibilities, and number of hours of diabetes education.
Participants in the intervention group will:
- receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies.
- 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.
Participants in the comparison group will:
- receive standard education provided to all patients at CHLA
- complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.
Detailed Description
Youth with type 1 diabetes (T1D) are at increased risk for kidney failure, vision loss, heart disease, and premature mortality due to challenges with glycemic excursions. Continuous glucose monitoring (CGM) systems represent an important advance in diabetes technology with significant advantages over self-monitored blood glucose and the potential to optimize glycemic management. Despite these advances, youth with T1D, including patients at Children's Hospital Los Angeles (CHLA), fail to achieve recommended glycemic targets, highlighting the opportunity for testing innovative diabetes education programs aimed at increased technology uptake such as the CGM Academy intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Everyone will know their assigned intervention.
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Current age of 8-18 years, age group eligible for CGM therapy with Dexcom G6 and G7
- •T1D duration ≥6 months, as insulin adjustments during honeymoon stage differs from establishedT1D
- •Able to speak, read, and write English or Spanish
- •Smartphone compatible with Dexcom G6 and G7application
- •Ability to participate in virtual visits
Exclusion Criteria
- •Known history of medical adhesive allergies
Arms & Interventions
CGM Academy
- receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies.
- 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.
Intervention: CGM Academy (Behavioral)
Standard Diabetes Education
- receive standard education provided to all patients at CHLA
- complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.
Outcomes
Primary Outcomes
Mean change in Hemoglobin A1c from baseline to 6 months
Time Frame: Baseline to 6 months
Change in Hemoglobin A1c
Secondary Outcomes
- Mean change in HbA1c (%) from baseline to 6 months.(Baseline to 6 months)
- Mean change in CGM metrics measured by CGM readings(Week 4 & 6 months)
- Change in perceived diabetes distress at baseline, week 4 & 6 months(Baseline, Week 4 & 6 months)
- Change in perceived diabetes family responsibility at baseline, week 4 & 6 months.(Baseline, week 4 & 6 months)
- Average number of diabetes educator hours used per study participant at week 4 & 6 months.(Week 4 and 6 months)
- Perceived benefits of Continuous Glucose Monitor (CGM) use(week 4 & 6 months)
- Perceived burden of Continuous Glucose Monitor (CGM) use(week 4 & 6 months)
Investigators
Barber, Rebecca
Principal Investigator
Children's Hospital Los Angeles