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

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ClinicalTrials.gov Identifier: NCT02246582
Recruitment Status : Completed
First Posted : September 23, 2014
Results First Posted : November 2, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Conditions Type 1 Diabetes
Type 2 Diabetes
Interventions Device: Enlite 3
Device: Guardian Mobile App
Device: 640G Insulin Pump
Enrollment 118
Recruitment Details  
Pre-assignment Details 118 subjects consented and enrolled in the overall study. Of the 118, 89 subjects utilized the latest sensor version.
Arm/Group Title Group A (FST 30 Mins After Sensor Insertion) Group B (FST 14 Hrs After Sensor Insertion)
Hide Arm/Group Description

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.

Guardian Mobile App

640G Insulin Pump

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.

Guardian Mobile App

640G Insulin Pump

Period Title: Overall Study
Started 44 45
Completed 41 41
Not Completed 3 4
Reason Not Completed
Withdrawal by Subject             3             4
Arm/Group Title All Subjects
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Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.

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.

Guardian Mobile App

640G Insulin Pump

Overall Number of Baseline Participants 89
Hide Baseline Analysis Population Description
Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
<=18 years
14
  15.7%
Between 18 and 65 years
62
  69.7%
>=65 years
13
  14.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants
41.7  (19.14)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
Female
43
  48.3%
Male
46
  51.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 89 participants
89
1.Primary Outcome
Title Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)
Hide Description 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.
Time Frame 7 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.
Arm/Group Title Group
Hide Arm/Group Description:

Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.

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.

Guardian Mobile App

640G Insulin Pump

Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: percentage
640G Pump 10.55  (9.62)
Guardian Mobile 10.35  (10.39)
2.Secondary Outcome
Title Retrospective Re-Analysis (MARD With 1 Additional Calibration)
Hide Description 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.
Time Frame 7 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.
Arm/Group Title Group
Hide Arm/Group Description:

Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.

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.

Guardian Mobile App

640G Insulin Pump

Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: percentage
640G Pump 9.64  (9.04)
Guardian Mobile 9.43  (9.83)
3.Secondary Outcome
Title Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)
Hide Description 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.
Time Frame 7 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.
Arm/Group Title Group
Hide Arm/Group Description:

Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.

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.

Guardian Mobile App

640G Insulin Pump

Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: percentage
minimum calibration 9.09  (8.29)
3-4 calibrations 8.68  (7.95)
Time Frame [Not Specified]
Adverse Event Reporting Description Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.
 
Arm/Group Title Group
Hide Arm/Group Description

Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.

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.

Guardian Mobile App

640G Insulin Pump

All-Cause Mortality
Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group
Affected / at Risk (%) # Events
Total   0/89 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group
Affected / at Risk (%) # Events
Total   5/89 (5.62%)    
Infections and infestations   
Gastroenteritis  1/89 (1.12%)  1
Upper respiratory infection  1/89 (1.12%)  1
Reproductive system and breast disorders   
worsening of BPH  1/89 (1.12%)  1
Skin and subcutaneous tissue disorders   
RASH  1/89 (1.12%)  1
Blister  1/89 (1.12%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Smita Barua, Clinical Trial Manager
Organization: Medtronic Diabtes
Phone: 818.576.5534
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02246582     History of Changes
Other Study ID Numbers: CEP292
First Submitted: September 11, 2014
First Posted: September 23, 2014
Results First Submitted: August 24, 2016
Results First Posted: November 2, 2016
Last Update Posted: November 2, 2016