Continuous Glucose Monitor, Type 1 Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
BEHAVIORALWeb-Based Education
Completion of a CGM specific web-based educational intervention that includes a series of online learning modules.
BEHAVIORALSocial Support
Engagement in peer-led CGM specific discussion boards
BEHAVIORALStandard of Care
Standard of Care - serves as the control group for the treatment arm
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, un-blinded intervention/control design
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
1. Ability to read and speak English 2. Diagnosed with type 1 diabetes (T1D) for \> 3 months before consent is obtained 3. Aged \>15 years and \<24 years at time of enrollment 4. Must have access to a smartphone, tablet or laptop/desktop computer with high speed internet access and speaker 5. Must be using/initiating a Dexcom CGM
Exclusion criteria
1. Cognitive or learning disability (e.g., inability to read) that would preclude their ability to comply with the study protocol 2. 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 3. Previous use of a CGM within the last 3 months 4. Unwilling or unlikely to return to clinic for a follow-up HbA1c test 5. Unwillingness to accept randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to CGM | 3 months | Analyzing CGM data to determine if there is a difference in adherence between treatment and control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 1-week run in, 3-months post implementation | 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. |
| CGM Satisfaction | 1-week run in, 7 weeks | Survey instrument that measures self-reported satisfaction with CGM use |
| CGM Self-Efficacy | 1-week run in, 7 weeks | Survey instrument that measures self-reported self-efficacy related to CGM use |
Countries
United States
Outcome results
None listed