Glycemic Metrics and Patterns in People With and Without Prediabetes

N/ARecruitingNCT06921902

Abbott Diabetes Care2,000 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Pre Diabetes

Interventions

FreeStyle Libre 3DEVICE

Abbott Sensor Based Glucose Monitoring System (FreeStyle Libre 3 System)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Diabetes and Obesity Care

Bend, Oregon, United States

RECRUITING

Outcomes

Primary Outcomes

Characterize the glycemic profiles of people with and without a prediabetes diagnosis.

This is a data collection study.

Time frame: up to 50 days

Central Contacts

MOHAMED NADA, PhD

CONTACT

5107495416 adc.clinical@abbott.com

Data from ClinicalTrials.gov

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