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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
  Purpose
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.

Condition Intervention
Type 1 Diabetes
Type 2 Diabetes
Device: Enlite 3
Device: Guardian Mobile App
Device: 640G Insulin Pump

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Performance Evaluation of the Enlite® 3 Sensor to Support a Full 168 Hours (7 Days) of Use

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 118
Study Start Date: September 2014
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
Subjects underwent FST at 30 mins, 50 hrs and 146 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
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 B
Subjects underwent FST at 14 hrs, 62 hrs and 158 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02246582

Locations
United States, California
AMCR Institute
Escondido, California, United States, 92026
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
Barbara Davis Center
Aurora, Colorado, United States, 80045
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Sponsors and Collaborators
Medtronic Diabetes
Investigators
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
  More Information

Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02246582     History of Changes
Other Study ID Numbers: CEP292
Study First Received: September 11, 2014
Results First Received: August 24, 2016
Last Updated: October 31, 2016

Keywords provided by Medtronic Diabetes:
Type 1 Diabetes
Type 2 Diabetes
Enlite 3

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 21, 2017