Continuous Glucose Monitoring in Prediabetes (G1)

University of Southern California

Status: Completed

Conditions: Pre-diabetes

Treatments: Device: The continuous glucose monitoring system

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06472297

UP-23-01001

P50MD017344 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Prediabetes by finger prick blood A1C%
• Centers for Disease Control and Prevention (CDC) prediabetes risk test score of 5 or higher
• Willingness to wear CGM sensor
• Latino community health worker

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
• Incompatible smartphone device not pairing with Dexcom G6 app

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Unmasked CGM feedback

Experimental group

Description:

The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment.

Treatment:

Device: The continuous glucose monitoring system