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Completed

NCT Number: NCT06472297

Continuous Glucose Monitoring in Prediabetes

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.

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Key information

Conditions

Pre-diabetes Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern California Center for Latino Health SCCLH

Los Angeles, California, 90031, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The continuous glucose monitoring system

Device

CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream.

Other names: CGM feedback

Primary outcomes

  1. Change in Mean Glucose (mg/dL) From Baseline

    Time frame: Up to 20 days of continuous CGM wear, comprising two sequential 10-day assessment periods (baseline Phase A and subsequent Phase B).

    Mean glucose was derived from continuous glucose monitoring (CGM) data obtained from the Dexcom Clarity system. Raw glucose values were processed and analyzed using the R statistical software package iglu to generate the full CGM variability metrics panel. For each participant, mean glucose was calculated separately for each 10-day assessment period. The outcome measure represents the change in mean glucose, defined as the difference between the baseline (Phase A) 10-day assessment period and the subsequent (Phase B) 10-day assessment period.

Other outcomes

  1. Total Duration of Participant-Generated Narrative Video Recordings

    Time frame: Up to 20 days during the CGM wear period, plus post-study interview recordings.

    Total duration, in minutes, of narrative video recordings generated by participants, including daily selfie-style reflections recorded during the continuous glucose monitor (CGM) wear period and post-study interview recordings (as a measure of feasibility).

    The total number of minutes of recorded narrative video content was calculated by summing the duration of all daily reflection videos and post-study interview recordings across participants. Results are reported as total minutes.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Diabetes Prevention Combining CGM and Artificial Intelligence Health Education

Acronym: G1

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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