Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

User Evaluation of the MiniMed 640G Insulin Pump

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT01991548
First received: November 18, 2013
Last updated: May 11, 2017
Last verified: March 2016
Results First Received: August 28, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Type 1 Diabetes
Type 2 Diabetes
Intervention: Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter

  Participant Flow
  Hide Participant Flow

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
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
STARTED   40 
COMPLETED   39 
NOT COMPLETED   1 



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
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]
 40 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      16  40.0% 
Between 18 and 65 years      24  60.0% 
>=65 years      0   0.0% 
Age 
[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
  Hide 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
No text entered.


  More Information
  Hide 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
ClinicalTrials.gov Identifier: NCT01991548     History of Changes
Other Study ID Numbers: CEP284
Study First Received: November 18, 2013
Results First Received: August 28, 2015
Last Updated: May 11, 2017