Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM Academy | Experimental |
|
|
| Standard Diabetes Education | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM Academy | Behavioral | Educational materials as well as online sessions with diabetes educators. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Hemoglobin A1c from baseline to 6 months | Change in Hemoglobin A1c | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in 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 in Range (70-180 mg/dL), % Glucose Time Below Range (<70mg/dL), % Glucose Time Above Range (>180mg/dL). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Known history of medical adhesive allergies
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Barber, PhD, RN | Contact | (323) 361-1359 | 11359 | rbarber@chla.usc.edu |
| Natalia Garban | Contact | ngarban@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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Simple randomization
Not provided
Not provided
Everyone will know their assigned intervention.
Not provided
| 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. | 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 |
| 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. | 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. | week 4 & 6 months |