Scripps Health
San Diego, California, 92121, United States
Location status: Recruiting
NCT Number: NCT07065721
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
San Diego, California, 92121, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: Immediately after the intervention
Mean rating of CGM feasibility, acceptability, utility, satisfaction ≥ 3/5 on a 0-5 scale
Time frame: 30 days (during the intervention period)
Percent of time that glucose readings are in target range (70-180 mg/dL)
Time frame: One week (7 days), last week of the intervention
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).
Time frame: Baseline and follow-up (immediately after the intervention)
Diabetes distress measured using the Problem Areas in Diabetes scale; range 0-80; higher score = higher diabetes distress
Time frame: Baseline and follow-up (immediately after the intervention)
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).
Time frame: Baseline and follow-up (immediately after the intervention)
Self-reported moderate and vigorous physical activity using the International Physical Activity Questionnaire (scored as metabolic equivalent units per week)
Time frame: 30 days (during the intervention period)
FitBit-sensed step count (weekly average)
Contact information is provided by the study sponsor or research team.
San Diego State University
Other
CAPAZ-2D: Continuous Glucose Monitoring to Augment and Personalize Self-Management of Type 2 Diabetes in Hispanic/Latinx Young Adults
Acronym: CAPAZ-2D
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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