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| ID | Type | Description | Link |
|---|---|---|---|
| IRB201701822 | Other Identifier | University of Florida |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-Based Educational Intervention | Experimental | 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. |
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| Standard of Care | Placebo Comparator | Participants will receive standard clinical care. Similar study measures will be collected to compare between groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-Based Education | Behavioral | Completion of a CGM specific web-based educational intervention that includes a series of online learning modules. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madison B Smith, BSN, PhD Candidate | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32603 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33560234 | Derived | Smith MB, Albanese-O'Neill A, Yao Y, Wilkie DJ, Haller MJ, Keenan GM. Feasibility of the Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitor (IDEAL CGM) Training and Follow-Up Support Intervention: Randomized Controlled Pilot Study. JMIR Diabetes. 2021 Feb 9;6(1):e15410. doi: 10.2196/15410. |
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Randomized, un-blinded intervention/control design
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| Social Support | Behavioral | Engagement in peer-led CGM specific discussion boards |
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| Standard of Care | Behavioral | Standard of Care - serves as the control group for the treatment arm |
|
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 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System 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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