NCT06472297

Continuous Glucose Monitoring in Prediabetes

Diabetes Prevention Combining CGM and Artificial Intelligence Health Education

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pre-diabetes

Interventions

Type	Name	Description
DEVICE	The continuous glucose monitoring system	CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream.

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2024-06-25
• Last updated: 2026-01-30
• Results posted: 2026-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study