Status:
COMPLETED
Adult Accuracy Study of the Enlite 3 Glucose Sensor
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 1 Diabetes
Type 2 Diabetes
Eligibility:
All Genders
14-75 years
Phase:
NA
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 ...
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 Guardia...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT02246582
Start Date
September 1 2014
End Date
August 1 2015
Last Update
November 2 2016
Active Locations (6)
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1
AMCR Institute
Escondido, California, United States, 92026
2
Diablo Clinical Research
Walnut Creek, California, United States, 94598
3
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
4
Barbara Davis Center
Aurora, Colorado, United States, 80045