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

Not Applicable

Completed

• Conditions: Continuous Glucose Monitor; Type 1 Diabetes Mellitus
• Interventions: Behavioral: Standard of Care; Behavioral: Web-Based Education; Behavioral: Social Support

• Registration Number: NCT03367351
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-08
• Study Start: 2018-03-09
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-14
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Participants will receive standard clinical care. Similar study measures will be collected to compare between groups.
Web-Based Educational Intervention	Web-Based Education	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.
Web-Based Educational Intervention	Social Support	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.

Primary Outcome Measures

Name	Time	Method
Adherence to CGM	3 months	Analyzing CGM data to determine if there is a difference in adherence between treatment and control group

Secondary Outcome Measures

Name	Time	Method
CGM Self-Efficacy	1-week run in, 7 weeks	Survey instrument that measures self-reported self-efficacy related to CGM use
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

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States