Continuous Glucose Monitoring in Prediabetes With Health Education Videos

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

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-14

Study Completion Date

2026-01-30

Brief Summary

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The objective of this project is to deliver a behavior health education video series that combines wearable continuous glucose monitoring (CGM) with smartphone feedback and video clips generated by artificial intelligence (AI) software to improve glycemic control among individuals with prediabetes. The goal is to prevent transition to type 2 diabetes and advanced metabolic complications.

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Detailed Description

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A health education video series, ¡Mi Control!, led by community health workers known as Promotores de Salud (PdS), will be integrated with continuous glucose monitoring (CGM) to support self-monitoring of glucose levels and excursions. Study G2 is a Phase 0 feasibility study enrolling 30 Spanish- and/or English-speaking PdS who 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.

Conditions

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Prediabetes

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

An AB sequential condition design with CGM automated continuous glucose recording with glucose level masked and unmasked phases.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

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.

Study Groups

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Single Group

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.

Group Type OTHER

CGM

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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
* 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