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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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FreeStyle Libre Flash Glucose Monitoring


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General
Study Status Progress Adequate
Application Number P160030 / PAS001
Study Name FreeStyle Libre Flash Glucose Monitoring
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a one-year prospective, multi-center, nonrandomized,
single-arm, post-approval study of the
FreeStyle Libre Flash CGM intended to characterize the
safety of the device when used in people with type 1 and
type 2 diabetes non-adjunctively in ages 18 years and up.
Subjects will utilize capillary SMBG for managing diabetes
for 6 months (control phase) followed by diabetes
management using the FreeStyle Libre Flash 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. Subjects will also complete a
-Quality of Life- questionnaire at the completion of the
control phase and the intervention phase. Up to 920 subjects
will be enrolled in up to 10 sites to obtain at least 736
subjects who complete the study. The purpose of this study
is to characterize the safety of the Libre Flash Glucose
Monitoring System when used in the intended use
population.
Study Population Description Adult (18 years of age and up) with type 1 and type 2 diabetes that meet the inclusion/exclusion criteria will be

studied.

The device is investigational in ages 4-17 years. The 4-17 year age group will also be studied under an approved IDE

G170269.

Inclusion Criteria:

Subjects will be considered for enrollment in the study if they meet all of the following criteria:

1. Subject must be at least 18 years of age

2. Subject must have a diagnosis of type 1 or type 2 diabetes mellitus

3. Subject is currently using SMBG for managing their diabetes

4. Subject must be able to read and understand English and/or Spanish

5. In the investigators 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

6. Subject must have access to an internet connected for uploading data from the blood glucose meter and FreeStyle Libre system.

7. Subject must be willing and able to provide written signed and dated informed consent and assent when appropriate.

Exclusion Criteria:

1. Subject is a member of the Site Staff

2. Subject is currently using or has previously used a continuous glucose monitoring system for managing their diabetes

3. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.

4. Subject is pregnant at the time of enrollment

5. Subject is on dialysis at the time of enrollment

6. 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

7. Subject currently participating in another clinical trial

8. Subject is unsuitable for participation due to any other cause as determined by the investigator.

Sample Size Up to 920 subjects will be enrolled
Data Collection Primary Endpoint:

An analysis of the rate of severe hypoglycemic and

hyperglycemic events will compare the intervention phase

(approximate days 180 to 365) to the control phase

(approximate days 1-180).

Secondary Endpoints:

BG frequency in the control and intervention phases

Scan frequency in the intervention phase

Change in HbA1c

DTSQ (Quality of Life Questionnaire).

Follow-up Visits and Length of Follow-up Follow-up visits are scheduled throughout the study period

for 12 months.



FreeStyle Libre Flash Glucose Monitoring Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/28/2018 03/26/2018 On Time
one year report 09/27/2018    
18 month report 03/28/2019    
two year report 09/27/2019    
three year report 09/26/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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