Continuous Glucose Monitoring in Prediabetes

NCT ID: NCT06472297

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Video narratives will be provided by Latino community health workers, known as Promotores de Salud (PdS), who will wear and experience the continuous glucose monitoring (CGM) system and its glycemic variability feedback. Study 1 (G1) is a Phase 0 intervention development study, enrolling a sample of 20 Spanish- and/or English-speaking PdS who test positive for pre-diabetes via a finger prick screening. Participants will wear CGM devices for 20 days, during which they will record daily narratives about their experiences with the CGM feedback and their glucose variability. Structured interviews between staff and participants will explore the benefits and barriers of CGM use. These recorded video clips will serve as the foundation for educational cinematic smartphone videos for future interventions. Artificial intelligence (AI) tools will be used to translate the text, audio, and video clips into various languages for broad dissemination. Blood glucose levels in mg/dL will be recorded continuously over the wear period.

Conditions

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Pre-diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A case series of participants wear an unmasked CGM sensor for a condition lasting 20 days while recording daily narratives of their experience.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

The CGM system feedback is unmasked. The CGM is automatically recorded and does not require an outcomes assessor.

Study Groups

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Unmasked CGM feedback

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

Group Type EXPERIMENTAL

The continuous glucose monitoring system

Intervention Type DEVICE

CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream.

Interventions

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The continuous glucose monitoring system

CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream.

Intervention Type DEVICE

Other Intervention Names

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CGM feedback

Eligibility Criteria

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Inclusion Criteria

* Prediabetes by finger prick blood A1C%
* Willingness to wear CGM sensor
* Latino 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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David S Black, PhD

Associate Professor of Population and Public Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David S Black, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Southern California Center for Latino Health SCCLH

Los Angeles, California, United States

Site Status

Countries

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United States

Related Links

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https://www.dexcom.com

Dexcom G CGM system specifications

Other Identifiers

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P50MD017344

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UP-23-01001

Identifier Type: -

Identifier Source: org_study_id

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