NCT07477249

Brief 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 (T2D).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Feb 2026Mar 2027

Study Start

First participant enrolled

February 26, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

March 12, 2026

Last Update Submit

March 25, 2026

Conditions

Prediabetes

Keywords

PrediabetesGlucose controlFeedbackHealth educationArtificial intelligenceBehavioral analysis

Outcome Measures

Primary Outcomes (1)

  • Glucose levels

    Mean glucose in mg/dL

    Maximum of 20 days of continuous wear

Secondary Outcomes (1)

  • Time out of range > 140 mg/dL (TOR)

    Maximum of 20 days of continuous wear

Study Arms (1)

Single Group: CGM with Masked Phase A and Unmasked Phase B

OTHER

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

Interventions

CGMDEVICE

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.

Single Group: CGM with Masked Phase A and Unmasked Phase B

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern California Center for Latino Health (SCCLH)

Los Angeles, California, 90031, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Prediabetic StateHealth Education

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • David S Black, PhD MPH

    University of Southern California Keck School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David S Black, PhD MPH

CONTACT

3234428223davidbla@usc.edu

Ruth Flores

CONTACT

rflores8@usc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants are blinded to glucose values during Phase A. The CGM system generates automated records of glucose and does not require observation from an outcomes assessor. The investigator does not engage with participants and becomes aware of unmasking after trial is completed.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Phase A / Phase B (AB) sequential condition design with CGM automated continuous glucose recording with glucose level masked and unmasked phases.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Tenured Associate Professor of Population and Public Health Sciences

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 17, 2026

Study Start

February 26, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
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.
Access Criteria
Publicly available link or by request to PI or directly obtained as supplemental material from the website of the journal publication.
More information

Locations

US(1)