adult accuracy study of the enlite 3 glucose sensor

Conditions: Type 1 Diabetes; Type 2 Diabetes

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.

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.

Eligibility criteria:
inclusion criteria: 1. subject is 14-75 years of age at time of screening 2. 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 3. adequate venous access as assessed by investigator or appropriate staff 4. 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: 1. subject will not tolerate tape adhesive in the area of enlite 3 sensor placement as assessed by qualified individual 2. subject has any unresolved adverse skin condition in the area of the enlite 3 sensor or device placement (e.g. psoriasis, rash, staphylococcus infection) 3. subject is actively participating in an investigational study (drug or device) in the last 2 weeks 4. subject is female and has a positive pregnancy screening test 5. 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 6. subject is female and plans to become pregnant during the course of the study 7. subject has had a hypoglycemic seizure within the past 6 months 8. subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit 9. subject has had an episode of diabetic ketoacidosis (dka) within the past 6 months prior to screening visit 10. subject has a history of a seizure disorder 11. subject has central nervous system or cardiac disorder resulting in syncope 12. 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 13. subject has a hematocrit (hct) lower than the normal reference range 14. subject has a history of adrenal insufficiency

Keywords: type 1 diabetes type 2 diabetes enlite 3