Clinical trial NCT03448380: FreeStyle Libre Flash Glucose Monitoring System Post Approval Study
Official title: FreeStyle Libre Flash Glucose Monitoring System Post Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2018-02-28
Enrollment: 935
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects aged 18 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes. At least 20% of the study population will be age 30 or below and 15% will be age 65 or older.

Brief summary: This is a prospective, multi-center, non-randomized, single-arm, post-approval study of the FreeStyle Libre Flash Glucose Monitoring System intended to characterize the safety of the Libre Flash Glucose Monitoring System when used in people with diabetes.

Detailed description: Up to 920 adult subjects, aged 18 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 736 subjects who complete the final visit. Subjects will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase). Subjects will maintain a diary/log book of Adverse Events during each phase. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.

Eligibility criteria: Inclusion Criteria:

* Subject must be at least 18 years of age.
* Subject must have a diagnosis of type 1 or type 2 diabetes mellitus.
* Subject is currently using SMBG for managing their diabetes.
* Subject must be able to read and understand English
* In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
* Subject must have access to an internet connected computer for uploading data from the blood glucose meter and FreeStyle Libre system.
* Subject must be willing and able to provide written signed and dated informed consent.

Exclusion Criteria:

* Subject is a member of the Site Staff.
* Subject is currently using or has previously used a continuous glucose monitoring system for managing their diabetes
* Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
* Subject is pregnant or is attempting to become pregnant at the time of enrollment.
* Subject is on dialysis at the time of enrollment.
* Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.
* Subject currently is participating in another clinical trial.
* Subject is unsuitable for participation due to any other cause as determined by the Investigator.

Primary outcomes:
measure: Safety of the FreeStyle Libre Flash Glucose Monitoring System
timeFrame: Approximately one year per subject.
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Miami
country: United States
facility: Baptist Diabetes Associates, P.A
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute
state: Florida
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes & Osteoporosis Center
state: Idaho
city: Des Moines
country: United States
facility: Iowa Diabetes & Endocrinology Research Center
state: Iowa
city: Waltham
country: United States
facility: MassResearch, LLC
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience Inc.
state: New Mexico
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
Study officials:
affiliation: Abbott Diabetes Care Inc
name: Shridhara A Karinka, PhD
role: STUDY_DIRECTOR
References: