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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
Results First Received: August 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Conditions: Type 1 Diabetes
Type 2 Diabetes
Interventions: Device: Enlite 3
Device: Guardian Mobile App
Device: 640G Insulin Pump

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
118 subjects consented and enrolled in the overall study. Of the 118, 89 subjects utilized the latest sensor version.

Reporting Groups
  Description
Group A (FST 30 Mins After Sensor Insertion)

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

Group B (FST 14 Hrs After Sensor Insertion)

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


Participant Flow:   Overall Study
    Group A (FST 30 Mins After Sensor Insertion)   Group B (FST 14 Hrs After Sensor Insertion)
STARTED   44   45 
COMPLETED   41   41 
NOT COMPLETED   3   4 
Withdrawal by Subject                3                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
All Subjects

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


Baseline Measures
   All Subjects 
Overall Participants Analyzed 
[Units: Participants]
 89 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      14  15.7% 
Between 18 and 65 years      62  69.7% 
>=65 years      13  14.6% 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.7  (19.14) 
Gender 
[Units: Participants]
Count of Participants
 
Female      43  48.3% 
Male      46  51.7% 
Region of Enrollment 
[Units: Participants]
 
United States   89 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)   [ Time Frame: 7 Days ]

2.  Secondary:   Retrospective Re-Analysis (MARD With 1 Additional Calibration)   [ Time Frame: 7 Days ]

3.  Secondary:   Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)   [ Time Frame: 7 Days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: smita.barua@medtronic.com



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