Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06408207
CGM Academy for Youth With Type 1 Diabetes
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
8 year–18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
CGM Academy
BehavioralEducational materials as well as online sessions with diabetes educators.
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.
Time frame: Baseline to 6 months
Change in Hemoglobin A1c
-
Mean change in CGM metrics measured by CGM readings
Time frame: Week 4 & 6 months
% Glucose Time in Range (70-180 mg/dL), % Glucose Time Below Range (<70mg/dL), % Glucose Time Above Range (>180mg/dL).
-
Change in perceived diabetes distress at baseline, week 4 & 6 months
Time frame: Baseline, Week 4 & 6 months
The Problem Areas in Diabetes survey (PAID) is an 18-item survey to assess the perceived burden associated with diabetes. Youth and caregivers are given statements about diabetes-related issues and report 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 for them. Increasing scores denote increased burden perceived.
-
Change in perceived diabetes family responsibility at baseline, week 4 & 6 months.
Time frame: 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.
Time frame: Week 4 and 6 months
Number of hours spent in diabetes education
-
Perceived benefits of Continuous Glucose Monitor (CGM) use
Time frame: week 4 & 6 months
Adolescent Benefits and Burdens of CGM Survey - BenCGM & BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree.
-
Perceived burden of Continuous Glucose Monitor (CGM) use
Time frame: week 4 & 6 months
Adolescent Benefits and Burdens of CGM Survey - BenCGM & BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Children's Hospital Los Angeles
Other
Registry information
Official study title
Randomized Control Trial Evaluating the Impact of CGM Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 1 Diabetes
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 10, 2024
- Registry last updated
- Feb 6, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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