Status:
COMPLETED
A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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...
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 tr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Subjects with a history of adrenal insufficiency
- Subjects with migraines
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01464346
Start Date
November 1 2011
End Date
March 1 2012
Last Update
May 30 2018
Active Locations (7)
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1
Profil Institute for Clinical Research
Chula Vista, California, United States, 91911
2
AMCR Institue
Escondido, California, United States, 92026
3
University of California, San Diego
La Jolla, California, United States, 92093
4
Diablo Clinical Research
Walnut Creek, California, United States, 94598