A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the performance and safety of the Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.

Detailed Description
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This study is a multi-center, randomized, prospective single-sample correlational design without controls. Up to 72 subjects will be enrolled in order to have approximately 60 subjects complete the study. Three investigational centers in China will be used during this study. Each subject will wear the following devices: • Two Enlite Sensors each connected to an iPro2 for approximately 6 days Sensor Location: • The 2 Enlite Sensors will be worn in the abdomen area. Investigational center staff will insert sensors and connect to the iPro2s. During the study, each subject will be randomized and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6). During the study, subjects will continue with their current diabetes regimen independent of the study devices. Subjects will be instructed by the investigational center that they are not to use the study devices (except for the study meter) for the management of their diabetes. The Study Meter may be used for treatment decisions and calibration of Enlite Sensor.

Official Title
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A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Enlite 1 connected to iPro2 recorder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 14 - 75 years of age at time of screening Subject has a clinical diagnosis of type 1 or 2 diabetes as determined via medical record or source documentation by an individual qualified to make a medical diagnosis Subject has adequate venous access as assessed by investigator or appropriate staff Subject is willing to follow the study procedures and willing to come to study visits. Subject is willing to perform at least 4 self-monitoring of blood glucose (SMBG) per day for 6 days Exclusion Criteria: Subject will not tolerate tape adhesive in the area of Enlite Sensor placement as assessed by qualified individual. Subject has any unresolved adverse skin condition in the area of study device or device placement (e.g., psoriasis, rash, Staphylococcus infection) 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 Subject is female and has a positive pregnancy screening test Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator Subject is female and plans to become pregnant during the course of the study Subject has a hematocrit (Hct) lower than the normal reference range Subject may not be on the research staff of those performing this study

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6). | Device: Enlite 1 connected to iPro2 recorder<br>* Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percentage of Enlite Sensor Values That Are Within 20% Agreement of Gold Standard (Yellow Springs Instrument (YSI) YSI Plasma Glucose Values) | Primary endpoint is the mean percentage of Enlite Sensor Values from primary sensor that are within 20% agreement of YSI plasma glucose values (within 20 mg/dL if YSI <= 80 mg/dL) during YSI frequent sampling testing (FST) days. | YSI FST days (Day 1, 3-4, or 6 of sensor wear) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD) | Enlite sensor values from primary sensor were compared to YSI plasma glucose values during YSI FST days (Day 1, 3-4, or 6). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). | YSI FST days (Day 1, 3-4, or 6 of sensor wear) | 
| Clarke Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values | Clarke Error Grid compared the paired primary sensor and YSI reference glucose values. Zone A represents a region where sensor values that are within 20% of YSI reference values, or both sensor and YSI reference values are less than 70 mg/dL. Values in Zone A are clinically accurate in that they would lead to clinically correct treatment decisions. Zone B represents sensor values that deviate YSI reference values by more than 20%, but would lead to benign or no treatment. Ideal situation is 100% in Zone A + B. | YSI FST days (Day 1, 3-4, or 6 of sensor wear) | 
| Consensus Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values | Consensus Error Grid (or Parkes error grid) compared the paired primary sensor and YSI reference glucose values. Zone A is defined in the Parkes error grid as the zone of clinical accurate measurements with no effect on clinical action, Zone B as altered clinical action with little or no effect on clinical outcome. Ideal situation is 100% in Zone A + B. | YSI FST days (Day 1, 3-4, or 6 of sensor wear) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Type I Type II