Adult Accuracy Study of the Enlite 3 Glucose Sensor

Completed · Not applicable

Conditions studied: Type 1 Diabetes, Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT02246582

Run by

Medtronic MiniMed, Inc.

People needed

118

Starts

2014-09-01

Expected to finish

2015-08-01

Last updated by the study team

2016-11-02

Who can join

Age: 14 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• AMCR Institute — Escondido, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
• Barbara Davis Center — Aurora, Colorado, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Rainier Clinical Research Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.