Continuous Glucose Monitoring for Self-Management of Type 2 Diabetes in Young Adults

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM)

• Registration Number: NCT07065721
• Lead Sponsor: San Diego State University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-06-05
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Study Start: 2025-07-31
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Qualitative data regarding CGM use	Immediately after the intervention	Semi-structured qualitative interviews will be conducted to understand barriers and facilitators of CGM use, changes in awareness of glucose patterns or relationships between glucose and health behaviors, and preferences for a future CGM-based intervention.

Secondary Outcome Measures

Name	Time	Method
Acceptability and feasibility of CGM wear	Immediately after the intervention	Mean rating of CGM feasibility, acceptability, utility, satisfaction ≥ 3/5 on a 0-5 scale

Trial Locations

Locations (1)

Scripps Health; 🇺🇸 San Diego, California, United States