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

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

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

Study Overview

• Status: Recruiting
• Conditions: Pre Diabetes
• Intervention / Treatment: Device: FreeStyle Libre 3

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: MOHAMED NADA, PhD; Phone Number: 5107495416; Email: adc.clinical@abbott.com

Study Locations

• United States
  • Oregon
    • Bend, Oregon, United States, 97702
      • Recruiting
      • Diabetes and Obesity Care
      • Contact: Eden Miller, D.O.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the glycemic profiles of people with and without a prediabetes diagnosis.	This is a data collection study.	up to 50 days

Collaborators and Investigators

• Sponsor: Abbott Diabetes Care
• Investigators: Study Chair: Shridhara Karinka, PhD, Abbott Diabetes Care

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperglycemia; Nutritional and Metabolic Diseases; Glucose Intolerance
• Other Study ID Numbers: ADC-US-RES-23243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No