Type 2 Diabetes
Conditions
Keywords
Continuous Glucose Monitoring, Glycemic Control, Diabetes Education, Type 2 Diabetes
Brief summary
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.
Interventions
BEHAVIORALContinuous Glucose Monitoring Academy
Educational materials as well as online sessions with diabetes educators.
BEHAVIORALStandard Education
Standard of care receives general education about diabetes.
Sponsors
Children's Hospital Los Angeles
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Current age of 8-21 years; 2. T2D diagnosis; 3. Able to speak, read, and write English or Spanish
Exclusion criteria
a. Known history of medical adhesive allergies;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Time in Range (TIR) from baseline to 6 months | Baseline to 6 months | Change in % glucose TIR (70-180 mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Hemoglobin A1c (HbA1c) from baseline to 6 months | Baseline to 6 months | Change in Hemoglobin A1c |
| Mean change in CGM metrics measured by CGM readings | Week 4 & 6 months | % Glucose Time Below Range (\<70mg/dL), % Glucose Time Above Range (\>180mg/dL), % Glucose Variability (coefficient of variation, CV) |
| Change in perceived diabetes distress at baseline, week 4 & 6 months | 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. |
| Change in perceived diabetes family responsibility at baseline, week 4 & 6 months | 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. | Week 4 and 6 months | Number of hours spent in diabetes education |
| Mean change in perceived benefits of Continuous Glucose (CGM) Monitor use | Week 4 & 6 months | 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. |
| Mean change in perceived burden of Continuous Glucose Monitor (CGM) use | Week 4 & 6 months | 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. |
Countries
United States
Contacts
CONTACTNatalia Garban
CONTACTRebecca Barber
PRINCIPAL_INVESTIGATORRebecca Barber, PhD, RN
Children's Hospital Los Angeles
Outcome results
None listed