FreeStyle Libre Flash Glucose Monitoring System Post Approval Study
1 other identifier
observational
935
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2018
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2018
CompletedStudy Start
First participant enrolled
February 27, 2018
CompletedFirst Posted
Study publicly available on registry
February 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedJune 16, 2021
June 1, 2021
3.1 years
February 22, 2018
June 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Safety of the FreeStyle Libre Flash Glucose Monitoring System
The study is designed to characterize the safety of the FreeStyle Libre Flash Glucose Monitoring System when used in the intended study population.
Approximately one year per subject.
Study Arms (1)
SMBG and FreeStyle Libre
During the intervention phase, subjects will use FreeStyle Libre Flash Glucose Monitoring System for 6 months to managed their diabetes.
Interventions
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).
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Sansum Diabetes Research Institute
Santa Barbara, California, 93105, United States
Baptist Diabetes Associates, P.A
Miami, Florida, 33156, United States
Metabolic Research Institute
West Palm Beach, Florida, 33401, United States
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
Iowa Diabetes & Endocrinology Research Center
Des Moines, Iowa, 50265, United States
MassResearch, LLC
Waltham, Massachusetts, 02453, United States
Henry Ford Medical Center
Detroit, Michigan, 48202, United States
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, 87109, United States
Texas Diabetes & Endocrinology
Round Rock, Texas, 78681, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shridhara A Karinka, PhD
Abbott Diabetes Care Inc
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2018
First Posted
February 28, 2018
Study Start
February 27, 2018
Primary Completion
March 30, 2021
Study Completion
March 30, 2021
Last Updated
June 16, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share