Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
continuous glucose monitor, type 2 diabetes, young adult
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.
Interventions
DEVICEContinuous 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.
Sponsors
Scripps Health
San Diego State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The intervention consists of a 30-day CGM wear and weekly surveys. Participants will be asked to maintain continuous use of CGM for 30 days and share their CGM data over that period. CGM sensors will be provided free-of-charge. Additionally, participants will be asked to complete weekly electronic surveys measuring self-management behaviors.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diabetes distress | 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 |
| Self-management motivation | 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). |
| Glucose time-in-range | 30 days (during the intervention period) | Percent of time that glucose readings are in target range (70-180 mg/dL) |
| Objectively measured physical activity | 30 days (during the intervention period) | FitBit-sensed step count (weekly average) |
| Self-reported physical activity | 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) |
| Diabetes self-care behaviors | 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). |
Countries
United States
Contacts
Primary ContactJessica L McCurley, PhD, MPH
Outcome results
None listed