Continuous Glucose Monitoring in Prediabetes

Last updated: February 27, 2025
Sponsor: University of Southern California
Overall Status: Completed

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Diabetes (Pediatric)

Treatment

The continuous glucose monitoring system

Clinical Study ID

NCT06472297
UP-23-01001
P50MD017344
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Prediabetes by finger prick blood A1C%

  • Willingness to wear CGM sensor

  • Latino community health worker

Exclusion

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

Study Design

Total Participants: 21
Treatment Group(s): 1
Primary Treatment: The continuous glucose monitoring system
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
September 30, 2024

Study 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.

Connect with a study center

  • Southern California Center for Latino Health SCCLH

    Los Angeles, California 90031
    United States

    Site Not Available

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