N/A
Completed N=80
In Clinic Evaluation of the PLGM Feature
Source: ClinicalTrials.gov NCT02130284 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Serious Adverse Events (SAE) — 0 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serious Adverse Events (SAE) |
— | — |
| PRIMARY Unanticipated Device Effect (UADE) |
— | — |
| PRIMARY Severe Hypoglycemia |
— | — |
| PRIMARY Diabetic Ketoacidosis |
— | — |
| PRIMARY Rescue Events During In-clinic Procedues |
7 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT02130284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.