FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients

Up to 400 pediatric subjects aged 4-17 years with type 1 or type 2 diabetes, who require
daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least
314 subjects who complete the final visit. Subjects and/or their caregivers 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 and/or their
caregivers 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 4 - 17 years of age.

- Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3
months prior to enrollment.

- Subject is currently using SMBG for managing their diabetes.

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

- In the investigator's opinion, the subject and/or caregiver 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 and/or caregiver must have access to an internet connected computer for
uploading data from the blood glucose meter and FreeStyle Libre system.

- Subject must have an overnight companion (caregiver 18 years or older) present in the
same home during participation of the study.

- Subject and/or parent or guardian must be willing and able to provide written signed
and dated informed consent and assent when appropriate.

Exclusion Criteria:

- Subject and/or caregiver 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 known to be 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.