Continuous Glucose Monitoring (CGM) in Prediabetes With Health Education Videos
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Glucose levels
Study Overview
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 (T2D).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
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.
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Single Group: CGM with Masked Phase A and Unmasked Phase B
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.
Intervention: CGM (Device)
Outcomes
Primary Outcomes
Glucose levels
Time Frame: Maximum of 20 days of continuous wear
Mean glucose in mg/dL
Secondary Outcomes
- Time out of range > 140 mg/dL (TOR)(Maximum of 20 days of continuous wear)
Investigators
David S Black, PhD
Tenured Associate Professor of Population and Public Health Sciences
University of Southern California