CEP249 Pediatric Accuracy Study

This study is a prospective, single arm, multi-center, in-clinic study.. There will be two
consecutive phases of the study:

A total of up to 260 subjects (2-18 years old) will be enrolled at up to 15 investigational
centers

Subjects will come for clinic visit for YSI reference glucose testing and for Enlite Sensor™
and Enlite 3 Sensor™ testing. SMBG (Self-Monitoring of Blood Glucose) reference measurement
is for subjects 2-6 years of age and cannot tolerate YSI.

Study has a run-in period and a study period with a total of 10 visits

Inclusion Criteria:

1. Subject is 2-18 years of age at time of screening

2. Subject has been diagnosed with insulin requiring diabetes mellitus for at least one
year.

3. Subject is willing to perform greater than or equal to 4 finger stick blood glucose
measurements daily

4. Subject is willing to perform required sensor calibrations

5. Subject is willing to wear the system (Guardian Mobile application, pumps, sensors,
meter) continuously throughout the study

6. Adequate venous access as assessed by investigator or appropriate staff

Exclusion Criteria:

1. Subject is unable to tolerate tape adhesive in the area of sensor placement

2. Subject has any unresolved adverse skin condition in the area of sensor or device
placement (e.g., psoriasis, rash, Staphylococcus infection)

3. Subject is actively participating in an investigational study (drug or device) wherein
they have received treatment from an investigational study (drug or device) in the
last 2 weeks

4. Females of child-bearing potential who have a positive pregnancy test at screening or
plans to become pregnant during the course of the study

5. Subjects with hematocrit lower than the normal age specific reference range per
central or local lab testing