Continuous Glucose Monitoring (CGM) in Prediabetes With Community Based Recruitment (G3)

March 25, 2026 updated by: David S Black, PhD

Continuous Glucose Monitoring (CGM) in Prediabetes With Health Education Videos

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 (T2D).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this new project is to enhance glycemic control in individuals with prediabetes and deter the progression to Type 2 Diabetes (T2D) within the Los Angeles (LA) County community. Our proposal involves conducting a Phase 0 intervention development study. This study will enlist a final sample of N=50 adults who speak English and/or Spanish, have non-clinical prediabetes, and 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 (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 35 years of age or older
  • Willingness to wear CGM sensor
  • Prediabetes by finger prick blood A1C% or fasting glucose
  • Centers for Disease Control and Prevention (CDC) prediabetes risk test score of 5 or higher or recent prediabetes diagnosis from physician

Exclusion Criteria:

  • 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
  • Currently pregnant
  • Previously participated in other Continuous Glucose Monitoring studies
  • Having a planned trip outside California in the following 2 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Group: CGM with Masked Phase A and Unmasked Phase B
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
Time Frame: Maximum of 20 days of continuous wear
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 Frame: Maximum of 20 days of continuous wear
Time out of range > 140 mg/dL (TOR)
Maximum of 20 days of continuous wear

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP-23-01001(b)
  • 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-Children's Hospital Los Angeles (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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prediabetes

Clinical Trials on CGM

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe