Glycemic Metrics and Patterns in People With and Without Prediabetes

NCT06921902 | Recruiting FDA Device

• 1 other identifier: ADC-US-RES-23243
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre Diabetes

Outcome Measures

Primary Outcomes (1)

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

  This is a data collection study.

  up to 50 days

Interventions

FreeStyle Libre 3 DEVICE

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

Also known as: FreeStyle Libre 3 Monitoring System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be stratified into groups, including male and female sex, race, age and Body Mass Index. Approximately 25 evaluable subjects will be enrolled into each group.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Diabetes Care: lead

Study Sites (1)

Diabetes and Obesity Care

Bend, Oregon, 97702, United States

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Shridhara Karinka, PhD

  Abbott Diabetes Care

  STUDY CHAIR

Central Study Contacts

MOHAMED NADA, PhD

CONTACT

5107495416; adc.clinical@abbott.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 10, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)