Continuous Glucose Monitoring in Prediabetes

NCT06472297 | Completed Results DMC FDA Device

• 2 other identifiers: UP-23-01001P50MD017344
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes

Keywords

Prediabetes; Glucose management; Feedback; Narrative education; Artificial intelligence; Contingency-shaped learning

Outcome Measures

Primary Outcomes (1)

• Change in Mean Glucose (mg/dL) From Baseline

  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.

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

Other Outcomes (1)

• Total Duration of Participant-Generated Narrative Video Recordings

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

Study Arms (1)

Unmasked CGM feedback

EXPERIMENTAL

The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment.

Device: The continuous glucose monitoring system

Interventions

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.

Also known as: CGM feedback

Unmasked CGM feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Southern California Center for Latino Health SCCLH

Los Angeles, California, 90031, United States

Location

Related Links

• Dexcom G CGM system specifications

MeSH Terms

Conditions

Glucose Intolerance; Prediabetic State

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Limitations and Caveats

The Phase 0 intervention goal raises few concerns regarding scientific rigor; however, focusing on a single major racial/ethnic group limits the generalizability of the content to other racial/ethnic groups, which will be addressed in future work.

Results Point of Contact

• Title: My Vu
• Organization: Children's Hospital Los Angeles

myvu@chla.usc.edu

323-361-8681

Study Officials

• David S Black, PhD MPH

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The CGM system feedback is unmasked. The CGM is automatically recorded and does not require an outcomes assessor.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Population and Public Health Sciences

Model Details: A case series of participants wear an unmasked CGM sensor for a condition lasting 20 days while recording daily narratives of their experience.

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: June 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: January 30, 2026
• Results First Posted: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 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: Request from author or see study publication supplemental material on the journal website.

Locations

US (1)