Adult Accuracy Study of the Enlite 3 Glucose Sensor

Not Applicable

Completed

Interventions: Device: Enlite 3
Device: Guardian Mobile App
Device: 640G Insulin Pump

Brief Summary: The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes.

Detailed Description: This study is a multi-center, randomized, in-clinic trial that aims to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes for at least one year.

Subjects are randomized into either Group A or Group B. The groups assigned will determine when the subject will be participating in the in-clinic YSI frequent sample testing (FST). For example on Day 1: Group A begins FST 30 minutes after Enlite 3 Sensor Insertion. Group B begins FST 14 hours after Enlite 3 Sensor Insertion.

Recruitment & Eligibility

Inclusion Criteria

Subject is 14-75 years of age at time of screening
A clinical diagnosis of type 1 or type 2 diabetes for a minimum of 12 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
Adequate venous access as assessed by investigator or appropriate staff
Subjects participating in the high and low glucose challenges must have an established insulin carbohydrate ratio(s) and insulin sensitivity ratio. (The term "established" refers to a ratio that has been previously defined and tested prior to screening visit). Subjects without established ratios may participate under observation only.

Exclusion Criteria

Subject will not tolerate tape adhesive in the area of Enlite 3 Sensor placement as assessed by qualified individual
Subject has any unresolved adverse skin condition in the area of the Enlite 3 Sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)
Subject is actively participating in 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 the investigator
Subject is female and plans to become pregnant during the course of the study
Subject has had a hypoglycemic seizure within the past 6 months
Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
Subject has a history of a seizure disorder
Subject has central nervous system or cardiac disorder resulting in syncope
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
Subject has a hematocrit (Hct) lower than the normal reference range
Subject has a history of adrenal insufficiency

Arm && Interventions

Group	Intervention	Description
Group B	640G Insulin Pump	Subjects underwent FST at 14 hrs, 62 hrs and 158 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
Group A	Guardian Mobile App	Subjects underwent FST at 30 mins, 50 hrs and 146 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
Group A	640G Insulin Pump	Subjects underwent FST at 30 mins, 50 hrs and 146 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
Group B	Enlite 3	Subjects underwent FST at 14 hrs, 62 hrs and 158 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
Group B	Guardian Mobile App	Subjects underwent FST at 14 hrs, 62 hrs and 158 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
Group A	Enlite 3	Subjects underwent FST at 30 mins, 50 hrs and 146 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR

Primary Outcome Measures

Name	Time	Method
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)	7 Days	Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Note that results from multiple testing days will be pooled together for reporting purpose.

Secondary Outcome Measures

Name	Time	Method
Retrospective Re-Analysis (MARD With 1 Additional Calibration)	7 Days	Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Note that results from multiple testing days will be pooled together for reporting purpose.
Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)	7 Days	Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Note that results from multiple testing days will be pooled together for reporting purpose.

Locations (6): Barbara Davis Center for Childhood Diabetes
🇺🇸
Aurora, Colorado, United States
AMCR Institute
🇺🇸
Escondido, California, United States
Diablo Clinical Research
🇺🇸
Walnut Creek, California, United States
Barbara Davis Center
🇺🇸
Aurora, Colorado, United States
Atlanta Diabetes Associates
🇺🇸
Atlanta, Georgia, United States
Rainier Clinical Research Center
🇺🇸
Renton, Washington, United States