Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring (IDEAL CGM)
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|ClinicalTrials.gov Identifier: NCT03367351|
Recruitment Status : Completed
First Posted : December 8, 2017
Last Update Posted : December 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus Continuous Glucose Monitor||Behavioral: Web-Based Education Behavioral: Social Support Behavioral: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, un-blinded intervention/control design|
|Masking:||None (Open Label)|
|Official Title:||Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring|
|Actual Study Start Date :||March 9, 2018|
|Actual Primary Completion Date :||November 1, 2018|
|Actual Study Completion Date :||November 1, 2018|
Experimental: Web-Based Educational Intervention
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
Completion of a CGM specific web-based educational intervention that includes a series of online learning modules.
Behavioral: Social Support
Engagement in peer-led CGM specific discussion boards
Placebo Comparator: Standard of Care
Participants will receive standard clinical care. Similar study measures will be collected to compare between groups.
Behavioral: Standard of Care
Standard of Care - serves as the control group for the treatment arm
- Adherence to CGM [ Time Frame: 3 months ]Analyzing CGM data to determine if there is a difference in adherence between treatment and control group
- HbA1c [ Time Frame: 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 [ Time Frame: 1-week run in, 7 weeks ]Survey instrument that measures self-reported satisfaction with CGM use
- CGM Self-Efficacy [ Time Frame: 1-week run in, 7 weeks ]Survey instrument that measures self-reported self-efficacy related to CGM use
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367351
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32603|
|Principal Investigator:||Madison B Smith, BSN, PhD Candidate||University of Florida|