Continuous Glucose Monitoring for Self-Management of Type 2 Diabetes in Young Adults (CAPAZ-2D)

San Diego State University

Status: Enrolling

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Device: Continuous glucose monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT07065721

IRB-24-8450

Details and patient eligibility

About

Type 2 diabetes in increasing common in young adults. Utilizing a mixed-methods, community-based approach, this study offers continuous glucose monitors (CGMs) to young adults with type 2 diabetes for 30 days, and collects both quantitative and qualitative data to understand barriers and facilitators of CGM use, participants' changes in awareness of glucose patterns while using the CGM, and preferences for a CGM-based self-management intervention.

Full description

The prevalence of type 2 diabetes (T2D) is rising in young adults and is associated with increased complications and reduced life expectancy. Poor adherence to diabetes self-management behaviors is common in young adulthood, often leading to poor glycemic control, and existing self-management interventions have had limited effectiveness in this age group. Continuous glucose monitors (CGMs) provide real-time glucose data that can support behavior change and reduce common self-management barriers such as glycemic unawareness, but their use in younger adults is limited. As "digital natives," young adults are well-poised to benefit from CGM interventions, particularly if they reduce barriers of standard self-management education (e.g., time burden). Qualitative data has shown that young adults are interested in CGM use but lack both access to CGMs and understanding of how to best utilize CGM data. The purpose of this proposal is to utilize a mixed-methods, community-engaged approach to generate pilot data for the development of a self-management intervention that pairs CGM glucose data with behavioral data (e.g., FitBit step count, dietary intake) to improve self-management and glycemic awareness and control. Young adults with T2D will be recruited to participate in a 30-day trial wear of CGMs, during which self-management behaviors will also be assessed. Afterward, qualitative interviews with participants will be conducted to understand barriers and facilitators of CGM use, changes in awareness of glucose patterns, and preferences for a CGM-based intervention.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult 18-45 years of age
• diagnosis of type 2 diabetes in the last 5 years, as evidenced in the electronic medical record
• no prior use or experience with wearable CGMs
• possession of a smart phone that is compatible with Dexcom CGM sensors (nearly all smartphones are compatible) and willing to download and utilize the Dexcom CGM app
• fluency in English or Spanish

Exclusion criteria

• severe mental illness (e.g., psychosis, suicidal ideation);
• pregnancy or <6 months postpartum

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

CGM Wear

Experimental group

Description:

Participants will wear a continuous glucose monitor for 30 days. They will also wear a FitBit activity tracker watch and complete weekly surveys to report diabetes self-management behaviors.

Treatment:

Device: Continuous glucose monitor