Glycemic Metrics and Patterns in People With and Without Prediabetes

NCT ID: NCT06921902

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-28

Study Completion Date

2026-07-31

Brief Summary

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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

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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.

Conditions

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Pre Diabetes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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FreeStyle Libre 3

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

Intervention Type DEVICE

Other Intervention Names

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FreeStyle Libre 3 Monitoring System

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Diabetes Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shridhara Karinka, PhD

Role: STUDY_CHAIR

Abbott Diabetes Care

Locations

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Diabetes and Obesity Care

Bend, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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MOHAMED NADA, PhD

Role: CONTACT

5107495416

Facility Contacts

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Eden Miller, D.O.

Role: primary

Other Identifiers

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ADC-US-RES-23243

Identifier Type: -

Identifier Source: org_study_id

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