Type 2 Continuous Glucose Monitoring Academy
NCT Number: NCT06516640
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes
Interventions: BEHAVIORAL: Continuous Glucose Monitoring Academy|BEHAVIORAL: Standard Education
Sponsor: Children's Hospital Los Angeles
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-06-30

Summary:
The goal of this clinical trial is to evaluate the Impact of CGM Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes:

* The first aim is to determine how feasible it is to adapt the CGM Academy curriculum to teach youth with T2D glucose management strategies.
* The second aim is to evaluate the effects of the CHLA CGM 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 CGM system (Dexcom or FreeStyle Libre) provided via insurance and inserted at the baseline visit.

Primary Outcome Measures: Mean change in Time in Range (TIR) from baseline to 6 months, Change in % glucose TIR (70-180 mg/dL), Baseline to 6 months
Secondary Outcome Measures: Mean change in Hemoglobin A1c (HbA1c) from baseline to 6 months, Change in Hemoglobin A1c, 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), 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., 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., 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, Week 4 and 6 months