CGM Academy for Youth With Type 1 Diabetes
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: CGM Academy.
- Who it may be relevant to
- Registry conditions: Type1 Diabetes. Basic parameters: 8 years — 18 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 →
Unsure about the terms? Read our patient guide →
Official title
Randomized Control Trial Evaluating the Impact of CGM Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 1 Diabetes
Overview
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.
Interventions
- Behavioral CGM Academy
Educational materials as well as online sessions with diabetes educators.
Primary outcome measures
- Mean change in Hemoglobin A1c from baseline to 6 months [Time frame: Baseline to 6 months]
Secondary outcome measures (7)
- Mean change in 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]
- Perceived benefits of Continuous Glucose Monitor (CGM) use [Time frame: week 4 & 6 months]
- Perceived burden of Continuous Glucose Monitor (CGM) use [Time frame: week 4 & 6 months]
Eligibility criteria
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
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: NCT06408207 · CHLA-23-00298