Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472297
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-18
Brief Title:
Continuous Glucose Monitoring in Prediabetes
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Diabetes Prevention Combining CGM and Artificial Intelligence Health Education
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
G1
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
Detailed Description:
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 In Study 1 G1 the investigator will conduct a Phase 0 intervention development study enrolling a sample of 20 Spanish- andor 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 The investigator will then use artificial intelligence tools to translate the text audio and video clips into various languages for broad dissemination Blood glucose levels in mgdL will be recorded continuously over the wear period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50MD017344 | NIH | None | None |