Continuous Glucose Monitoring in Prediabetes
- Conditions
- Pre-diabetes
- Interventions
- Device: The continuous glucose monitoring system
- Registration Number
- NCT06472297
- Lead Sponsor
- University of Southern California
- Brief Summary
The objective of this project is to develop a behavioral intervention that combines wearable continuous glucose monitoring (CGM) with smartphone feedback and educational video clips generated by artificial intelligence (AI) software to improve glycemic control among individuals with pre-diabetes. The goal is to prevent transition to type 2 diabetes.
- Detailed Description
Video narratives will be provided by Latino community health workers, known as Promotores de Salud (PdS), who will wear and experience the continuous glucose monitoring (CGM) system and its glycemic variability feedback. Study 1 (G1) is a Phase 0 intervention development study, enrolling a sample of 20 Spanish- and/or English-speaking PdS who test positive for pre-diabetes via a finger prick screening. Participants will wear CGM devices for 20 days, during which they will record daily narratives about their experiences with the CGM feedback and their glucose variability. Structured interviews between staff and participants will explore the benefits and barriers of CGM use. These recorded video clips will serve as the foundation for educational cinematic smartphone videos for future interventions. Artificial intelligence (AI) tools will be used to translate the text, audio, and video clips into various languages for broad dissemination. Blood glucose levels in mg/dL will be recorded continuously over the wear period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- Prediabetes by finger prick blood A1C%
- Willingness to wear CGM sensor
- Latino community health worker
- Currently pregnant
- Less than 18 years of age, which is adult in California
- Diagnosed with any disorder that interferes with glucose
- Influential medical disorder/event affecting ability to participate in study
- Incompatible smartphone device not pairing with Dexcom G6 app
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Unmasked CGM feedback The continuous glucose monitoring system The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment.
- Primary Outcome Measures
Name Time Method Glucose levels maximum of 20 days of continuous wear Mean glucose in mg/dL with glucose variability
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Southern California Center for Latino Health SCCLH
🇺🇸Los Angeles, California, United States