FreeStyle Libre Flash Glucose Monitoring System Post Approval Study



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/25/2019
Start Date:February 27, 2018
End Date:March 2021
Contact:Mohamed A Nada, PhD
Email:mohamed.nada@abbott.com
Phone:5107495416

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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.

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.

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.
We found this trial at
9
sites
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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Albuquerque, New Mexico 87109
Phone: 505-848-3773
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Albuquerque, NM
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Des Moines, Iowa 50314
Phone: 515-329-6807
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Des Moines, IA
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Idaho Falls, Idaho 83404
Principal Investigator: David Liljenquist, MD
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Idaho Falls, ID
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Miami, Florida 33156
Phone: 305-595-8252
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Miami, FL
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Round Rock, Texas 78681
Phone: 512-334-3505
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Round Rock, TX
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Santa Barbara, California 93105
Principal Investigator: Kristin Castorino, DO
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Santa Barbara, CA
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Waltham, Massachusetts 02453
Phone: 781-647-7200
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Waltham, MA
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West Palm Beach, Florida
Phone: 561-479-8458
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West Palm Beach, FL
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