N/A
Completed N=90
A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use
Source: ClinicalTrials.gov NCT01464346 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With Minimum Calibration, Combined Abdomen and Buttock Insertion Sites — 88.01 percentage of paired readings — p=<0.05
Summary
The purpose of this study is to demonstrate the performance of the Enlite Sensor over an entire calibration and wear period of 146 hours (6 days) when inserted in the abdomen and buttock and used with the Revel 2.0 Pumps in subjects age 18 - 75 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With Minimum Calibration, Combined Abdomen and Buttock Insertion Sites |
88.01 | <0.05 sig |
| SECONDARY Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With 3-4 Calibrations Per Day, Combined Abdomen and Buttock Insertion |
90.52 | < 0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Subject is 18 - 75 years of age at time of screening
- A clinical diagnosis of type 1 or 2 diabetes as determined by the
Investigator, for a minimum of 12 months duration:
- Criteria for type 1 diabetes:
- Required: Age of onset < 40 years of age
- Required: History of insulin use only for management of diabetes
- Required: history of normal weight or underweight at time of diagnosis.
- Not required: Initial presentation of diabetic ketoacidosis.
- Not required: History of diabetic ketoacidosis
- Not required: Low fasting C-peptide
- Criteria for type 2 diabetes:
- Required: Age of onset ~ 40 years of age
- Required: History of initial oral anti-diabetic use
- Required: History of being overweight at time of diagnosis.
- Type 2 insulin requiring is defined by type 2 diabetes subjects taking insulin with or without oral anti-diabetic agent and may also include: incretin mimetic, pramlintide or GLP agonist
- Type 2 non-insulin requiring is defined by type 2 diabetes subjects who take oral medications and may also include: incretin mimetic, pramlintide or GLP agonist
- Adequate venous access as assessed by investigator or appropriate staff
Exclusion Criteria
- 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 pregnancy screening test
- 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 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 lower than 36%
- SUbjects with a history of any cardiac arrhythmia, including atrial arrhythmias
- Subjects with a history of adrenal insufficiency
- Subjects with migraines
Data sourced from ClinicalTrials.gov (NCT01464346). 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.