Recruiting

CGM with AI

Sponsor:

David S Black, PhD

Code:

NCT07477249

Conditions

Prediabetes

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Accepted

Interventions

CGM

Study Details

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).

Conditions

Prediabetes

Study ID

NCT07477249

Start date

Feb 26, 2026

Status verified date

Mar, 2026

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Glucose levels [ Time Frame: Maximum of 20 days of continuous wear ]

Central Contacts and Locations

Central contacts

David S Black, PhD MPH

3234428223davidbla@usc.edu

Ruth Flores

rflores8@usc.edu

Locations

Southern California Center for Latino Health (SCCLH)

Recruiting

Los Angeles, California, United States, 90031

More Information

Sponsor

David S Black, PhD

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • Prediabetes
  • Glucose control
  • Feedback
  • Health education
  • Artificial intelligence
  • Behavioral analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by David S Black, PhD on 2026-03-30.