FreeStyle LIbre Flash Glucose Monitoring System Pediatric Accuracy Study

Therapuetic Areas:Endocrinology
Age Range:4 - 17
Start Date:January 29, 2019
End Date:July 1, 2019
Contact:Mohamed Nada, Ph.D.

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The purpose of this study is to characterize the Freestyle Libre Flash Glucose Monitoring
System in pediatric subjects with respect to YSI reference venous plasma sample measurements.

Up to 250 subjects will be enrolled at up to six (6) clinical research sites in the United
States. Subjects will wear two Sensors. Each Sensor will have a paired Reader that will be
given to the subject. All Readers will be masked during the study (i.e. subjects will not be
able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be
asked to perform at least 4 capillary Blood Glucose (BG) tests per day using the primary
Reader. Interstitial glucose readings from each Sensor will be obtained with the
corresponding Readers immediately following each BG test. Subjects will be instructed to
report any problems with the device. Subjects will make three (3), four (4) or five (5)
scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit
1). Based on the subjects weight, subjects will have up to two (2) in-clinic visits during
which intravenous blood draws and YSI reference testing will occur.

Inclusion Criteria:

- Subject must be between the ages of 4 and 17 years of age at the time of study

- Subject must have type 1 or type 2 diabetes.

- Subjects age 11 and older must require insulin therapy through an insulin pump and/or
multiple daily insulin injections (at least 3 injections daily).

- Willing to perform a minimum of 4 finger sticks per day while wearing the sensor in
the study.

- Subject and/or guardian must be able to read and understand English.

- For subjects age 6 and older: willing to allow medical personnel to insert an IV
catheter in the arm to allow for venous blood flow samples to be obtained per the
study protocol.

- For subjects age 11 and older: subject is willing to have their blood sugar
manipulated during one or more in-clinic sessions.

- 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

- At the time of enrollment, subject must be available to participate in all study

- Known insulin sensitivity factor (only applicable to subjects age 11 and older).

- Subject's parent, guardian or legally authorized representative must be willing and
able to provide written informed consent.

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

Exclusion Criteria:

- Subject is 18 years of age or older.

- Subject has a history of hypoglycemia unawareness (only applicable to subjects age 11
and older).

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

- Subject is known to be pregnant or becomes pregnant during the study (applicable to
female subjects only).

- Subject has extensive skin changes/diseases at the proposed application sites that
could interfere with device placement or the accuracy of interstitial glucose
measurements. Such conditions include, but are not limited to extensive psoriasis,
recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis
herpetiformis, skin lesions, redness, infection or edema.

- Subject has had an episode of severe hypoglycemia requiring intervention from a health
care professional(i.e. EMT assistance, emergency room visit, or hospital admission)
within the last six (6) months (only applicable to subjects age 11 or older).

- Subject has had an episode of diabetic ketoacidosis (DKA) within the last (3) months
(only applicable to subjects age 11 or older).

- Subject is currently participating in another clinical trial.

- Subject has donated blood within 112 days (3.7 months) prior to the beginning of the
study activities (only applicable to subjects age 6 and older).

- Subject has both hemoglobin (Hb) and hematocrit levels that are below the normal
ranges (only applicable to subjects age 6 and older). The low end of the normal range
for Hb is as follows: for males and females aged 6-12 years old it is 11.5 g/dL; for
males aged 12-17 it is 13.0 g/dL; for females aged 12-17 it is 12.0 g/dL. The low end
of the normal hematocrit for males and females aged 6-12 is 35%; 37% for males aged
12-17 and 36% for females aged 12- 17).

- Subject has X-ray, MRI, CT or diathermy appointment scheduled during the period of
study participation, and the appointment cannot be rescheduled for a time before study
participation starts or after study participation ends.

- Subject is unsuitable for participation due to any other cause as determined by the
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