Type1 Diabetes
Conditions
Keywords
Continuous Glucose Monitoring, Glycemic Control, Diabetes Education, Type1 Diabetes
Brief summary
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: * Do participants undertaking the proposed curriculum present improved glucose variation than participants of standard education? * Explore relationships between participant's glycemic outcomes with diabetes distress, diabetes family responsibilities, and number of hours of diabetes education. Participants in the intervention group will: * receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies. * 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. Participants in the comparison group will: * receive standard education provided to all patients at CHLA * complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.
Detailed description
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.
Interventions
BEHAVIORALCGM Academy
Educational materials as well as online sessions with diabetes educators.
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Everyone will know their assigned intervention.
Intervention model description
Simple randomization
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Current age of 8-18 years, age group eligible for CGM therapy with Dexcom G6 and G7 * T1D duration ≥6 months, as insulin adjustments during honeymoon stage differs from establishedT1D * Able to speak, read, and write English or Spanish * Smartphone compatible with Dexcom G6 and G7application * Ability to participate in virtual visits
Exclusion criteria
• Known history of medical adhesive allergies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Hemoglobin A1c from baseline to 6 months | Baseline to 6 months | Change in Hemoglobin A1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in 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 in Range (70-180 mg/dL), % Glucose Time Below Range (\<70mg/dL), % Glucose Time Above Range (\>180mg/dL). |
| Change in perceived diabetes distress at baseline, week 4 & 6 months | 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. |
| 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 |
| Perceived benefits of Continuous Glucose Monitor (CGM) use | week 4 & 6 months | Adolescent Benefits and Burdens of CGM Survey - BenCGM \& BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree. |
| Perceived burden of Continuous Glucose Monitor (CGM) use | week 4 & 6 months | 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
CONTACTRebecca Barber, PhD, RN
CONTACTNatalia Garban
PRINCIPAL_INVESTIGATORRebecca Barber, PhD, RN
Children's Hospital Los Angeles
Outcome results
None listed