Continuous Glucose Monitoring in Prediabetes

Not Applicable

Recruiting

• 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. In Study 1 (G1), we will conduct 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. We will then use artificial intelligence tools 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.

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-01
• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-18
• Last Update Submitted: 2024-06-18
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Pre-diabetes by finger prick
• Willingness to wear CGM sensor
• Latino community health worker

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Exclusion Criteria

• 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

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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	20 days	Mean glucose in mg/dL with glucose variability

Trial Locations

Locations (1)

Southern California Center for Latino Health SCCLH; 🇺🇸 Los Angeles, California, United States