Glycemic Metrics and Patterns in People With and Without Prediabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FreeStyle Libre 3.
- Who it may be relevant to
- Registry conditions: Pre Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observation and Identification of Glycemic Metrics and Patterns in People With and Without Prediabetes (PREMAP)
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.
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.
Interventions
- Device FreeStyle Libre 3
Abbott Sensor Based Glucose Monitoring System (FreeStyle Libre 3 System)
Primary outcome measures
- Characterize the glycemic profiles of people with and without a prediabetes diagnosis. [Time frame: up to 50 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Diabetes and Obesity Care — Bend
Identifiers
NCT: NCT06921902 · ADC-US-RES-23243