- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03448380
FreeStyle Libre Flash Glucose Monitoring System Post Approval Study
June 14, 2021 updated by: Abbott Diabetes Care
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
935
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Santa Barbara, California, United States, 93105
- Sansum Diabetes Research Institute
-
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Florida
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Miami, Florida, United States, 33156
- Baptist Diabetes Associates, P.A
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West Palm Beach, Florida, United States, 33401
- Metabolic Research Institute
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Rocky Mountain Diabetes & Osteoporosis Center
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Iowa
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Des Moines, Iowa, United States, 50265
- Iowa Diabetes & Endocrinology Research Center
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Massachusetts
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Waltham, Massachusetts, United States, 02453
- MassResearch, LLC
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Medical Center
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New Mexico
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Albuquerque, New Mexico, United States, 87109
- Albuquerque Neuroscience Inc.
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Texas
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Round Rock, Texas, United States, 78681
- Texas Diabetes & Endocrinology
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San Antonio, Texas, United States, 78229
- Clinical Trials of Texas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
SMBG and FreeStyle Libre
During the intervention phase, subjects will use FreeStyle Libre Flash Glucose Monitoring System for 6 months to managed their diabetes.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of the FreeStyle Libre Flash Glucose Monitoring System
Time Frame: Approximately one year per subject.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Shridhara A Karinka, PhD, Abbott Diabetes Care Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2018
Primary Completion (Actual)
March 30, 2021
Study Completion (Actual)
March 30, 2021
Study Registration Dates
First Submitted
February 22, 2018
First Submitted That Met QC Criteria
February 22, 2018
First Posted (Actual)
February 28, 2018
Study Record Updates
Last Update Posted (Actual)
June 16, 2021
Last Update Submitted That Met QC Criteria
June 14, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- ADC-US-PMS-17168-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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