In Clinic Evaluation of the PLGM Feature
Completed · Not applicable
Conditions studied: Type 1 Diabetes
In brief
This study is a multi-center, single arm and in-clinic study to evaluate the safety of the PLGM System and its algorithm with the Enlite 3 Sensor.
Key facts
- Study ID
- NCT02130284
- Run by
- Medtronic MiniMed, Inc.
- People needed
- 80
- Starts
- 2014-10-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2017-09-28
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
- Subject has a clinical diagnosis of type 1 diabetes, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- Inclusion Criteria that are Based on Demands of In-Clinic Study Procedures
- On pump therapy at the time of screening with insulin sensitivity and insulin carbohydrate ratio
- Adequate venous access as assessed by investigator or appropriate staff
You may not qualify if…
- Exclusion Criteria that are Based on Demands of In-Clinic Study Procedures
- 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 urine or serum pregnancy screening test
- Subject is female, sexually active without use of contraception and plans to become pregnant during the course of the study
- Subject has had a hypoglycemic induced seizure within the past 6 months prior to screening visit
- 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
- Subjects with hematocrit (Hct) lower than the normal reference range for age per local lab testing
- Subjects with a history or findings on screening electrocardiogram (EKG) of any cardiac arrhythmia, including atrial arrhythmias
- Subjects with a history of adrenal insufficiency
- Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment
Where it is running
- AMCR Institute, Inc. — Escondido, California, United States
- Stanford University Department of Pediatric Endocrinology — Stanford, California, United States
- Diablo Clinical Research — Walnut Creek, California, United States
- Barbara Davis Center of Childhood Diabetes — Denver, Colorado, United States
- Yale University Diabetes Research Program — New Haven, Connecticut, United States
- Atlanta Diabetes Associates — Atlanta, Georgia, United States
- University of Virgina — Charlottesville, Virginia, United States
- Rainier Clinical Research — Renton, Washington, United States
Full record on ClinicalTrials.gov
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