Glycemic Metrics and Patterns in People With and Without Prediabetes

Recruiting

• Conditions: Pre Diabetes

• Registration Number: NCT06921902
• Lead Sponsor: Abbott Diabetes Care

Brief Summary

The FreeStyle Libre 3 Continuous Glucose Monitoring (FSL3) System is used to characterize the glycemic profiles of people with and without a prediabetes diagnosis.

Detailed Description

This is a non-pivotal, non-randomized, multi-center, prospective, non-significant risk to evaluate the glycemic profiles of people with and without a prediabetes diagnosis using continuous glucose monitoring. Up to 2000 subjects will be enrolled in up to 20 sites. Approximately 50% of evaluable subjects will have a prediabetes diagnosis.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-02-28
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Subject must be at least 18 years of age.
• Subject must be willing and able to provide written signed and dated informed consent.

Exclusion Criteria

• Subject has a diagnosis of type 1 diabetes, type 2 diabetes, or gestational diabetes.
• Subject is known to be currently practicing a low-carbohydrate or ketogenic diet at the time of enrollment.
• Subject is known to be pregnant at the time of enrollment.
• Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.
• Subject is currently on any form of treatment indicated for the treatment of diabetes.
• Subject is currently on any form of medication indicated for weight loss.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterize the glycemic profiles of people with and without a prediabetes diagnosis.	up to 50 days	This is a data collection study.

Trial Locations

Locations (1)

Diabetes and Obesity Care; 🇺🇸 Bend, Oregon, United States