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

Type 1 Diabetes Mellitus Clinical Trial

— IDEAL CGM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03367351
• Other study ID #: UFT1DCGM2017
• Secondary ID: IRB201701822
• Status: Completed
• Phase: N/A
• Start date: March 9, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: December 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Continuous Glucose Monitor
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Web-Based Education
Completion of a CGM specific web-based educational intervention that includes a series of online learning modules.
• Social Support
Engagement in peer-led CGM specific discussion boards
• Standard of Care
Standard of Care - serves as the control group for the treatment arm

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to CGM	Analyzing CGM data to determine if there is a difference in adherence between treatment and control group	3 months
Secondary	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
Secondary	CGM Satisfaction	Survey instrument that measures self-reported satisfaction with CGM use	1-week run in, 7 weeks
Secondary	CGM Self-Efficacy	Survey instrument that measures self-reported self-efficacy related to CGM use	1-week run in, 7 weeks