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In Clinic Evaluation of the PLGM Feature (PLGM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT02130284
First received: April 18, 2014
Last updated: February 14, 2017
Last verified: February 2017
Results First Received: February 14, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Type 1 Diabetes
Intervention: Device: Predictive Low Glucose Management Feature in 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
No text entered.

Reporting Groups
  Description
Predictive Low Glucose Management (PLGM)

To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor

Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.


Participant Flow:   Overall Study
    Predictive Low Glucose Management (PLGM)
STARTED   80 
COMPLETED   71 
NOT COMPLETED   9 
Withdrawal by Subject                3 
Subject Withdrew Consent                1 
Subject's sensor failed at Visit 2, Day                1 
Subject was screened as backup for study                3 
Screen Failure                1 



  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.
No text entered.

Reporting Groups
  Description
Predictive Low Glucose Management (PLGM)

To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor

Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.


Baseline Measures
   Predictive Low Glucose Management (PLGM) 
Overall Participants Analyzed 
[Units: Participants]
 80 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      14  17.5% 
Between 18 and 65 years      63  78.8% 
>=65 years      3   3.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.0  (16.90) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      45  56.3% 
Male      35  43.8% 
Region of Enrollment 
[Units: Participants]
 
United States   80 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Serious Adverse Events (SAE)   [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]

2.  Primary:   Unanticipated Device Effect (UADE)   [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]

3.  Primary:   Severe Hypoglycemia   [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]

4.  Primary:   Diabetic Ketoacidosis   [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]

5.  Primary:   Rescue Events During In-clinic Procedues   [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]

6.  Other Pre-specified:   PLGM Performance - Hypoglycemia Event Rate at Threshold of YSI <= 65 mg/dL.   [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]

7.  Other Pre-specified:   Sensor Performance: Accuracy   [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]

8.  Other Pre-specified:   Device Metric/Performance - All Device Deficiencies   [ Time Frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures ]


  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: Suiying Huang, Statistician
Organization: Medtronic Minimed
phone: 818-576-3319
e-mail: suiying.huang@medtronic.com



Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02130284     History of Changes
Other Study ID Numbers: CEP 272 PLGM
Study First Received: April 18, 2014
Results First Received: February 14, 2017
Last Updated: February 14, 2017