Glycemic Metrics and Patterns in People With and Without Prediabetes (PREMAP)

Abbott

Status: Enrolling

Conditions: Pre Diabetes

Treatments: Device: FreeStyle Libre 3

Study type: Observational

Funder types: Industry

Identifiers

NCT06921902

ADC-US-RES-23243

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.