FreeStyle Libre Glucose Monitoring System in Pediatric Populations

Up to 85 subjects will be enrolled at up to four (4) 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 four (4) to 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 at least 6 years of age.

- Subject must weigh at least 26 kg (57.2 lbs.).

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

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

- Subject must be currently performing at least four (4) capillary blood glucose
tests per day.

- Subject is willing to perform a minimum of 4 finger sticks per day during the
study.

- Subject is willing to allow medical personnel to insert at IV catheter in the arm
to allow for venous blood samples to be obtained per the study protocol.

- Subject and/or guardian 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 be available to participate in all study visits.

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

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

- Exclusion Criteria:

- Subject is 18 years of age or older.

- Subject weighs less than 26 kg (57.2 lbs.).

- 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 is currently participating in another clinical trial.

- Subject has had significant blood loss within 112 days (3.7 months) prior to the
beginning of the study activities subjects.

- Subject is anemic, defined as having hemoglobin levels below 11.5 g/dL for
subjects aged 6-11 years old, less than 12.0 g/dL for subjects aged 12-15 years
old, less than 12.0 g/dL for females aged 15-17 and less than 13.0 g/dL for males
aged 15-171, or as determined by investigator.

- Subject has X-ray, MRI or CT 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 Investigator.