Continuous Glucose Monitoring (CGM) in Prediabetes With Community Based Recruitment (G3)

David S Black, PhD

Status: Enrolling

Conditions: Prediabetes

Treatments: Device: CGM

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07477249

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

UP-23-01001(b)

Details and patient eligibility

About

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).

Full description

The primary objective of this new project is to enhance glycemic control in individuals with prediabetes and deter the progression to Type 2 Diabetes (T2D) within the Los Angeles (LA) County community. Our proposal involves conducting a Phase 0 intervention development study. This study will enlist a final sample of N=50 adults who speak English and/or Spanish, have non-clinical prediabetes, and 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: 50 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Single Group: CGM with Masked Phase A and Unmasked Phase B

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