An interventional study of CGM Academy in Type1 Diabetes, sponsored by Children's Hospital Los Angeles. Recruiting at 1 site in United States. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Treatment
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:
Participants in the intervention group will:
Participants in the comparison group will:
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.
Children's Hospital Los Angeles is the lead sponsor of 150 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* 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.
Behavioral: CGM Academy
* receive standard education provided to all patients at CHLA * complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.
Educational materials as well as online sessions with diabetes educators.
Mean change in Hemoglobin A1c from baseline to 6 months
Change in Hemoglobin A1c
Time frame: Baseline to 6 months
Mean change in HbA1c (%) from baseline to 6 months.
Change in Hemoglobin A1c
Time frame: Baseline to 6 months
Mean change in CGM metrics measured by CGM readings
% Glucose Time in Range (70-180 mg/dL), % Glucose Time Below Range (\<70mg/dL), % Glucose Time Above Range (\>180mg/dL).
Time frame: Week 4 & 6 months
Change in perceived diabetes distress at 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.
Time frame: Baseline, Week 4 & 6 months
Change in perceived diabetes family responsibility at 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.
Time frame: Baseline, week 4 & 6 months
Average number of diabetes educator hours used per study participant at week 4 & 6 months.
Number of hours spent in diabetes education
Time frame: Week 4 and 6 months
Perceived benefits of Continuous Glucose Monitor (CGM) use
Adolescent Benefits and Burdens of CGM Survey - BenCGM \& BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree.
Time frame: week 4 & 6 months
Perceived burden of Continuous Glucose Monitor (CGM) use
Adolescent Benefits and Burdens of CGM Survey - BenCGM \& BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree.
Time frame: week 4 & 6 months
Plan to share: No
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Children's Hospital Los Angeles