ClinicalTrials.gg
RecruitingNCT06921902PREMAPUpdated Apr 9, 2026

Glycemic Metrics and Patterns in People With and Without Prediabetes

An observational study in Pre Diabetes, sponsored by Abbott Diabetes Care. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by Abbott Diabetes Care (part of Abbott) · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pre Diabetes

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03

In context

Glucose Intolerance

793 studies on the registry are indexed under Glucose Intolerance; 115 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 218 across 109 observational studies indexed under Glucose Intolerance.

Browse Glucose Intolerance studies →

Lead sponsor

Abbott Diabetes Care is the lead sponsor of 43 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Interventions

  • DeviceFreeStyle Libre 3

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

    Also known as: FreeStyle Libre 3 Monitoring System

06

What researchers measure

Primary outcomes

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

    This is a data collection study.

    Time frame: up to 50 days

07

Study locations

1 of 1 sites recruiting
  • Diabetes and Obesity Care
    Bend, Oregon 97702, United States
    Recruiting
    • Eden Miller, D.O. · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06921902
Responsible party
Sponsor
First posted
Apr 10, 2025
Start date
Feb 28, 2025
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 9, 2026

Study contacts

MOHAMED NADA, PhD
Contact
adc.clinical@abbott.com
5107495416
Shridhara Karinka, PhD
study chair · Abbott Diabetes Care

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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