A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use
Condition: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Enlite Sensor
Intervention type(s): Device
Intervention description(s): This is the Enlite sensor (all subjects)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: diabetes; glucose sensor; CGM