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| ID | Type | Description | Link |
|---|---|---|---|
| P50MD017344 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Receives standard of care, regular education in the clinic. |
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| Continuous Glucose Monitoring Academy | Experimental | Receive an interactive workbook with problem-based learning scenarios and video links about Continuous Glucose Monitoring and glucose management strategies (CGM Academy Program). 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring Academy | Behavioral | Educational materials as well as online sessions with diabetes educators. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Time in Range (TIR) from baseline to 6 months | Change in % glucose TIR (70-180 mg/dL) | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
a. Known history of medical adhesive allergies;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalia Garban | Contact | 3233611359 | ngarban@chla.usc.edu | |
| Rebecca Barber | Contact | 3233611359 | rbarber@chla.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Barber, PhD, RN | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard Education | Behavioral | Standard of care receives general education about diabetes. |
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| 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 |
| 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. | 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. | Week 4 & 6 months |
| D004700 | Endocrine System Diseases |