N/A
Completed N=89
Adult Accuracy Study of the Enlite 3 Glucose Sensor
Source: ClinicalTrials.gov NCT02246582 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD) — 10.55; 10.35 percentage
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD) |
10.55; 10.35 | — |
| SECONDARY Retrospective Re-Analysis (MARD With 1 Additional Calibration) |
9.64; 9.43 | — |
| SECONDARY Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration) |
9.09; 8.68 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02246582). 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.