Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring

Study Overview
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Brief Summary
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The goal of this pilot study is to produce a high-quality, theory-driven, therapeutic, web-based intervention that provides extended training and peer support to adolescents and young adults with type 1 diabetes who are newly implementing CGM. Overall, this web-based intervention represents an efficient way to bring together professionally-supported CGM educational materials and social support to overcome known barriers and address factors associated with inconsistent CGM use.

Official Title
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Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring

Conditions
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Type 1 Diabetes Mellitus, Continuous Glucose Monitor

Intervention / Treatment
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* Behavioral: Web-Based Education
* Behavioral: Social Support
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to read and speak English Diagnosed with type 1 diabetes (T1D) for > 3 months before consent is obtained Aged >15 years and <24 years at time of enrollment Must have access to a smartphone, tablet or laptop/desktop computer with high speed internet access and speaker Must be using/initiating a Dexcom CGM Exclusion Criteria: Cognitive or learning disability (e.g., inability to read) that would preclude their ability to comply with the study protocol Significant medical comorbidity in the adolescent or young adult that could, in the opinion of the PI, affect subject's capacity to follow study protocol Previous use of a CGM within the last 3 months Unwilling or unlikely to return to clinic for a follow-up HbA1c test Unwillingness to accept randomization

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, un-blinded intervention/control design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-Based Educational Intervention<br>Participants receiving the Web-Based Educational Intervention will be enrolled to the research protocol for six weeks of module-based learning and online discussion sessions and followed for a total of 3-months post CGM implementation to collect study measures. | Behavioral: Web-Based Education<br>* Completion of a CGM specific web-based educational intervention that includes a series of online learning modules.<br>Behavioral: Social Support<br>* Engagement in peer-led CGM specific discussion boards<br>|
| Placebo Comparator: Standard of Care<br>Participants will receive standard clinical care. Similar study measures will be collected to compare between groups. | Behavioral: Standard of Care<br>* Standard of Care - serves as the control group for the treatment arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to CGM | Analyzing CGM data to determine if there is a difference in adherence between treatment and control group | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of control of diabetes. Collected through a blood sample. | 1-week run in, 3-months post implementation | 
| CGM Satisfaction | Survey instrument that measures self-reported satisfaction with CGM use | 1-week run in, 7 weeks | 
| CGM Self-Efficacy | Survey instrument that measures self-reported self-efficacy related to CGM use | 1-week run in, 7 weeks |