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Adult Accuracy Study of the Enlite 3 Glucose Sensor (E3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT02246582
First received: September 11, 2014
Last updated: October 31, 2016
Last verified: October 2016

September 11, 2014
October 31, 2016
September 2014
August 2015   (Final data collection date for primary outcome measure)
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD) [ Time Frame: 7 Days ]
Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.
Enlite 3 Sensor accuracy [ Time Frame: 3 Days ]
Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during the frequent sample testings.
Complete list of historical versions of study NCT02246582 on ClinicalTrials.gov Archive Site
  • Retrospective Re-Analysis (MARD With 1 Additional Calibration) [ Time Frame: 7 Days ]
    Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.
  • Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration) [ Time Frame: 7 Days ]
    Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.
Retrospective Re-Analysis [ Time Frame: 7 Days ]
Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values).
Not Provided
Not Provided
 
Adult Accuracy Study of the Enlite 3 Glucose Sensor
A Performance Evaluation of the Enlite® 3 Sensor to Support a Full 168 Hours (7 Days) of Use
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.

This study is a multi-center, randomized, in-clinic trial that aims 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 for at least one year.

Subjects are randomized into either Group A or Group B. The groups assigned will determine when the subject will be participating in the in-clinic YSI frequent sample testing (FST). For example on Day 1: Group A begins FST 30 minutes after Enlite 3 Sensor Insertion. Group B begins FST 14 hours after Enlite 3 Sensor Insertion.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Type 1 Diabetes
  • Type 2 Diabetes
  • Device: Enlite 3
    Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
  • Device: Guardian Mobile App
  • Device: 640G Insulin Pump
  • Group A
    Subjects underwent FST at 30 mins, 50 hrs and 146 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
    Interventions:
    • Device: Enlite 3
    • Device: Guardian Mobile App
    • Device: 640G Insulin Pump
  • Group B
    Subjects underwent FST at 14 hrs, 62 hrs and 158 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
    Interventions:
    • Device: Enlite 3
    • Device: Guardian Mobile App
    • Device: 640G Insulin Pump
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
August 2015
August 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject is 14-75 years of age at time of screening
  2. 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
  3. Adequate venous access as assessed by investigator or appropriate staff
  4. 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:

  1. Subject will not tolerate tape adhesive in the area of Enlite 3 Sensor placement as assessed by qualified individual
  2. Subject has any unresolved adverse skin condition in the area of the Enlite 3 Sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)
  3. Subject is actively participating in an investigational study (drug or device) in the last 2 weeks
  4. Subject is female and has a positive pregnancy screening test
  5. 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
  6. Subject is female and plans to become pregnant during the course of the study
  7. Subject has had a hypoglycemic seizure within the past 6 months
  8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
  9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
  10. Subject has a history of a seizure disorder
  11. Subject has central nervous system or cardiac disorder resulting in syncope
  12. 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
  13. Subject has a hematocrit (Hct) lower than the normal reference range
  14. Subject has a history of adrenal insufficiency
Sexes Eligible for Study: All
14 Years to 75 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
Canada
 
NCT02246582
CEP292
Yes
Not Provided
Not Provided
Not Provided
Medtronic Diabetes
Medtronic Diabetes
Not Provided
Principal Investigator: Ronald Brazg, M.D Rainier Clinical Research Center
Principal Investigator: Mark Christiansen, M.D Diablo Clinical Research
Principal Investigator: Timothy Bailey, M.D AMCR Institute
Principal Investigator: Satish Garg, M.D Barbara Davis Center
Principal Investigator: Robert Slover, M.D Barbara Davis Center
Principal Investigator: Bruce Bode, M.D Atlanta Diabetes Associates
Medtronic Diabetes
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP