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

CAPAZ-2D: Continuous Glucose Monitoring to Augment and Personalize Self-Management of Type 2 Diabetes in Hispanic/Latinx Young Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Device: Continuous glucose monitor

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica L McCurley, PhD, MPH; Phone Number: 619-594-2132; Email: jlmccurley@sdsu.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Recruiting
      • Scripps Health
      • Contact: Samantha Bagsic, PhD; Phone Number: 858-554-5708; Email: Bagsic.Samantha@scrippshealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM Wear; 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.	Device: Continuous glucose monitor; Participants will wear a continuous glucose monitoring sensor for 30 days. They will also wear a FitBit wrist watch to be able to track their physical activity and they will complete weekly surveys to report diabetes self-management behaviors. After the 30 days, they will participate in a qualitative interview to respond to questions about their experiences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative data regarding CGM use	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.	Immediately after the intervention

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose time-in-range	Percent of time that glucose readings are in target range (70-180 mg/dL)	30 days (during the intervention period)
Diabetes self-care behaviors	Self-report of diabetes self-management behaviors (e.g., healthy eating, physical activity) in the last 7 days using the 13-item Summary of Diabetes Self-care Behaviors Scale (range 0-91, higher = more frequent self-management behaviors).	One week (7 days), last week of the intervention
Diabetes distress	Diabetes distress measured using the Problem Areas in Diabetes scale; range 0-80; higher score = higher diabetes distress	Baseline and follow-up (immediately after the intervention)
Self-management motivation	Motivation and attitudes about behavioral diabetes self-management utilizing the 9-item Motivation and Attitudes Toward Changing Health measure (range: 9-45, higher scores = greater motivation/more positive attitude).	Baseline and follow-up (immediately after the intervention)
Self-reported physical activity	Self-reported moderate and vigorous physical activity using the International Physical Activity Questionnaire (scored as metabolic equivalent units per week)	Baseline and follow-up (immediately after the intervention)
Objectively measured physical activity	FitBit-sensed step count (weekly average)	30 days (during the intervention period)

Collaborators and Investigators

• Sponsor: San Diego State University
• Collaborators: Scripps Health
• Investigators: Principal Investigator: Jessica L McCurley, PhD MPH, San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: June 5, 2025
• First Submitted That Met QC Criteria: July 9, 2025
• First Posted (Actual): July 15, 2025

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: young adult; type 2 diabetes; continuous glucose monitor
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB-24-8450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the very small size of this study, data will not be shared, as there is risk of identifying participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes