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

University of Florida

Status: Completed

Conditions: Type 1 Diabetes Mellitus; Continuous Glucose Monitor

Treatments: Behavioral: Social Support; Behavioral: Web-Based Education; Behavioral: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03367351

UFT1DCGM2017

IRB201701822 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 15 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups, including a placebo group

Web-Based Educational Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Social Support

Behavioral: Web-Based Education

Standard of Care

Placebo Comparator group

Description:

Participants will receive standard clinical care. Similar study measures will be collected to compare between groups.

Treatment:

Behavioral: Standard of Care