Continuous Glucose Monitoring in Prediabetes With Health Education Videos Among Community Health Workers (G2)

Continuous Glucose Monitoring in Prediabetes With Health Education Videos

The objective of this project is to deliver a behavior health education video series that combines wearable continuous glucose monitoring (CGM) with smartphone feedback and video clips generated by artificial intelligence (AI) software to improve glycemic control among individuals with prediabetes. The goal is to prevent transition to type 2 diabetes and advanced metabolic complications.

Study Overview

• Status: Completed
• Conditions: Prediabetes
• Intervention / Treatment: Device: CGM

Detailed Description

A health education video series, ¡Mi Control!, led by community health workers known as Promotores de Salud (PdS), will be integrated with continuous glucose monitoring (CGM) to support self-monitoring of glucose levels and excursions. Study G2 is a Phase 0 feasibility study enrolling 30 Spanish- and/or English-speaking PdS who test positive for prediabetes via a finger-prick A1c% screening. Participants will wear CGM devices for 20 days, with glucose data masked for the first 10 days and unmasked for the next 10 days. During the unmasked phase, participants will receive daily health education videos on their smartphones. The study will compare the duration of glucose excursions between the masked and unmasked phases to assess the impact of CGM feedback and health education on glucose regulation.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90031
      • Southern California Center for Latino Health SCCLH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Group; Participants wear a CGM on the back of the arm. During Phase A, glucose values are not visible to participants. During Phase B, glucose values are visible via the phone app.	Device: CGM; The CGM sensor is worn on the back of the arm and glucose levels are recorded continuously but levels are not shown on the participant's phone app in phase A.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose levels	Mean glucose in mg/dL	Maximum of 20 days of continuous wear

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time out of range > 140 mg/dL (TOR)	Time out of range > 140 mg/dL (TOR)	Maximum of 20 days of continuous wear

Collaborators and Investigators

• Sponsor: David S Black, PhD
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: David S Black, PhD MPH, University of Southern California Keck School of Medicine

Publications and helpful links

Helpful Links

• Dexcom G CGM system specifications

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2025
• Primary Completion (Actual): November 3, 2025
• Study Completion (Actual): November 3, 2025

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Glucose control; Prediabetes; Artificial intelligence; Health education; Feedback; Behavioral analysis
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Behavior; Nutritional and Metabolic Diseases; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Adherence Interventions; Medication Adherence; Prediabetic State; Health Education
• Other Study ID Numbers: UP-23-01001(a); 3P50MD017344-03S3 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD sharing is set up with affiliate USC-CHLA P50 Center universities and hospitals under a registered data use agreement (DUA). Data and protocol documentation will be posted on the Open Science Framework
• IPD Sharing Time Frame: No longer than one year after the completion of the trial. Researchers can obtain de-identified data and statistical codes after publication of the study outcomes by email request and as supplemental material in future journal publications.
• IPD Sharing Access Criteria: Publicly available link or by request to PI or directly obtained as supplemental material from the website of the journal publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No