Continuous Glucose Monitoring in Prediabetes With Health Education Videos (G2)

David S Black, PhD

Status: Enrolling

Conditions: Prediabetes

Treatments: Device: CGM

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06883812

3P50MD017344-03S3 (U.S. NIH Grant/Contract)

UP-23-01001(a)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single Group

Other group

Description:

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.

Treatment:

Device: CGM