User Evaluation of the MiniMed 640G Insulin Pump

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01991548
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Information provided by (Responsible Party):
Medtronic Diabetes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Type 1 Diabetes
Type 2 Diabetes
Intervention: Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Insulin Dependent Diabetics Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 640G insulin pump and Guardian Link transmitter.

Participant Flow:   Overall Study
    Insulin Dependent Diabetics

  Baseline Characteristics

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.
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Reporting Groups
Insulin Dependent Diabetics individuals with insulin dependant diabetes using the 640G insulin pump for insulin infusion and continuous glucose monitoring

Baseline Measures
   Insulin Dependent Diabetics 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      16  40.0% 
Between 18 and 65 years      24  60.0% 
>=65 years      0   0.0% 
[Units: Years]
Mean (Standard Deviation)
 31.7  (17.74) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      18  45.0% 
Male      22  55.0% 

  Outcome Measures

1.  Primary:   User Acceptance of the New MiniMed 640G Insulin Pump and Guardian Link Transmitter   [ Time Frame: Four weeks of pump wear ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Clinical Research Manager
Organization: Medtronic Diabetes
phone: 818-576-5000

Responsible Party: Medtronic Diabetes Identifier: NCT01991548     History of Changes
Other Study ID Numbers: CEP284
First Submitted: November 18, 2013
First Posted: November 25, 2013
Results First Submitted: August 28, 2015
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017