A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use

A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use

The purpose of this study is to demonstrate the performance of the Enlite Sensor over an entire calibration and wear period of 146 hours (6 days) when inserted in the abdomen and buttock and used with the Revel 2.0 Pumps in subjects age 18 - 75 years.

The study is a multi-center, prospective single-sample correlational design without controls. Between 4 and 10 investigational sites will be used during this study. All subjects will be assigned to treatment. Each subject will wear the following devices:

1. Enlite Sensors (2) connected to MiniLinks (2)
2. Revel 2.0 Pumps (2)

During the study each subject will be wearing 2 sensors and 2 pumps simultaneously. The pumps will be differentiated by color, and will have different calibration requirements during the in-clinic portions of the study. During the Frequent Sampling Tests:

• GREEN pump will be calibrated 3-4 times spread throughout the day
• RED pump will have the minimum calibration requirements (every 12 hours after the second calibration)

During home use (outside the clinic) BOTH pumps will be calibrated 3-4 times spread throughout the day.

Sensors will be connected to the MiniLink (integrated with the Revel 2.0 Pumps)

Subjects will wear the devices for a 3-day training period, followed by a 6-day study period. During the study period, each subject will undergo three 12-hour Frequent Sampling Tests. During the Frequent Sampling Tests, IV blood samples will be drawn every 5-15 minutes and analyzed using the YSI. The Frequent Sampling Tests will occur during the following hours of sensor wear: hours 2-14, hours 14-26, hours 50-62 hours 62-74, and hours 122-134 hours 134-146 which is representative of a complete calibration and wear period to support the proposed labeling claim of 144 hours of use.

Even though participants were randomly assigned with respect to timing of frequent sample test and sensor insertion locations, data was collected as a whole and there was no intention to analyze the two groups separately. Please note that subjects were randomly assigned to one of 3 different sensor insertion site combinations: abdomen/abdomen, buttock/buttock, and abdomen/buttock

During each Frequent Sampling Test, subjects with an established insulin sensitivity ratio and insulin carbohydrate ratio will undergo a hypoglycemic challenge (glucose lowered to a target of 50-75 mg/dL for ~2 hours, including 30 minutes between 50-60 mg/dL) and a hyperglycemic challenge (glucose raised to a target of 180-400 mg/dL for ~2 hours, including 30 minutes between 350 -400 mg/dL). Subjects will continue with their current diabetes regimen (including glucose monitoring with their own meter when desired) independent of the study devices. The Revel 2.0 Pumps will not be used to infuse insulin or manage the subject's diabetes during this study. The Enlite Glucose sensor will not be used to manage the subject's diabetes during this study. The investigational Study Meter may be used for confirmation of alarms, treatment decisions and calibration of sensor.

Inclusion Criteria:

1. Subject is 18 - 75 years of age at time of screening

2. A clinical diagnosis of type 1 or 2 diabetes as determined by the

   Investigator, for a minimum of 12 months duration:

   • Criteria for type 1 diabetes:

     • Required: Age of onset < 40 years of age
     • Required: History of insulin use only for management of diabetes
     • Required: history of normal weight or underweight at time of diagnosis.
     • Not required: Initial presentation of diabetic ketoacidosis.
     • Not required: History of diabetic ketoacidosis
     • Not required: Low fasting C-peptide

   • Criteria for type 2 diabetes:

     • Required: Age of onset ~ 40 years of age

     • Required: History of initial oral anti-diabetic use

     • Required: History of being overweight at time of diagnosis.

       • Type 2 insulin requiring is defined by type 2 diabetes subjects taking insulin with or without oral anti-diabetic agent and may also include: incretin mimetic, pramlintide or GLP agonist
       • Type 2 non-insulin requiring is defined by type 2 diabetes subjects who take oral medications and may also include: incretin mimetic, pramlintide or GLP agonist

3. 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. Subject has a positive pregnancy screening test
5. Subject is female and plans to become pregnant during the course of the study
6. Subject has had a hypoglycemic seizure within the past 6 months
7. Subject has a history of a seizure disorder
8. Subject has central nervous system or cardiac disorder resulting in syncope
9. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
10. Subjects with hematocrit lower than 36%
11. SUbjects with a history of any cardiac arrhythmia, including atrial arrhythmias
12. Subjects with a history of adrenal insufficiency
13. Subjects with migraines