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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Educational materials as well as online sessions with diabetes educators.
Standard of care receives general education about diabetes.
Children's Hospital Los Angeles
Los Angeles, California, United States
RECRUITINGMean change in Time in Range (TIR) from baseline to 6 months
Change in % glucose TIR (70-180 mg/dL)
Time frame: Baseline to 6 months
Mean change in Hemoglobin A1c (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 Below Range (\<70mg/dL), % Glucose Time Above Range (\>180mg/dL), % Glucose Variability (coefficient of variation, CV)
Time frame: Week 4 & 6 months
Change in perceived diabetes distress at baseline, week 4 & 6 months
The Type 2 Diabetes Distress Assessment System (T2-DDAS) measures how much overall emotional distress is due to diabetes. Respondents are given statements about diabetes-related issues and indicate 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. 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
Mean change in perceived benefits of Continuous Glucose (CGM) Monitor use
Name of questionnaire: 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
Mean change in perceived burden of Continuous Glucose Monitor (CGM) use
Name of questionnaire: 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
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