A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use
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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.
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Type 1 or type 2 diabetes mellitus adult subjects 18-75 years of age
Subject is 18 - 75 years of age at time of screening
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
Adequate venous access as assessed by investigator or appropriate staff
Subject is unable to tolerate tape adhesive in the area of sensor placement.
Subject has any unresolved adverse skin condition in the area of sensor 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 has a positive pregnancy screening test
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 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
Subjects with hematocrit lower than 36%
SUbjects with a history of any cardiac arrhythmia, including atrial arrhythmias