Pre Diabetes
Conditions
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.
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
DEVICEFreeStyle Libre 3
Abbott Sensor Based Glucose Monitoring System (FreeStyle Libre 3 System)
Sponsors
Abbott Diabetes Care
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize the glycemic profiles of people with and without a prediabetes diagnosis. | up to 50 days | This is a data collection study. |
Countries
United States
Contacts
CONTACTMOHAMED NADA, PhD
STUDY_CHAIRShridhara Karinka, PhD
Abbott Diabetes Care
Outcome results
None listed