Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

User Evaluation of the MiniMed 620G and 640G Insulin Pumps

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: NCT01726621
Recruitment Status : Completed
First Posted : November 15, 2012
Results First Posted : April 18, 2016
Last Update Posted : April 18, 2016
Information provided by (Responsible Party):
Medtronic Diabetes

Brief Summary:

This six center international study will include two United Kingdom National Health Service centers, two centers in Melbourne, Australia and one center each in Denmark and Spain. The objective of the study is to evaluate subject acceptance of the a new insulin pump and transmitter together with the accompanying training materials. Descriptive data from participant questionnaires and device uploads will be evaluated.

Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of age upwards, who currently use an insulin pump in the management of their type 1 or type 2 diabetes, will be invited to participate. Each subject will be trained on the study device and then use it for approximately six weeks. During this time there will be three in-clinic visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of this period, they will revert back to their original insulin pump and complete a questionnaire on the study pump training materials, features and usability.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Type 2 Diabetes Device: Medtronic MiniMed 620G or 640G Insulin Pump Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A User Evaluation of the MiniMed® 620G and 640G Insulin Pumps and Guardian® Link Transmitter
Study Start Date : March 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Insulin dependent diabetics
Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter
Device: Medtronic MiniMed 620G or 640G Insulin Pump
Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks.

Primary Outcome Measures :
  1. User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter [ Time Frame: Four weeks of pump wear ]
    Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 620G, 640G, and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   7 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject is 7 years or older at time of screening
  • Subject is current insulin pump user for at least 3 months
  • Subject has the following Continuous Glucose Monitoring experience as determined by the Investigator:

    • Has experience and is able to insert/change sensor by herself/himself and
    • Has experience and can recharge the transmitter and
    • Has experience and can read sensor data in real-time on her/his pump screen
  • Subject has signed a Patient Informed Consent form and is willing to comply with the study procedures;
  • Subject is willing to complete study questionnaires throughout the study
  • Must have one of the following clinical diagnosis:

    • Type 1 diabetes, for a minimum of 6 months prior to enrollment
    • Insulin requiring type 2 diabetes, for a minimum of 6 months prior to enrollment

Exclusion Criteria:

  • Female subject has a positive urine pregnancy screening test.
  • Female subject who plans to become pregnant during the course of study. If a woman becomes pregnant during participation, she will be withdrawn
  • Subject has any condition that, in the opinion of the Investigator or qualified Investigational Center staff, may preclude him/her from participating in the study and completing study related procedures.
  • Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Center staff
  • Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01726621

Layout table for location information
St Vincent Hospital and The University of Melbourne
Fitzroy, Australia, 3065
The Royal Melbourne Hospital
Patkville, Australia, 3050
Herlev Hospital
Herlev, Denmark
Barcelona University Hospital
Barcelona, Spain, 08036
United Kingdom
University College Hospital
London, United Kingdom, NW1 2PG
King's College London
London, United Kingdom, SE5 9NU
Sponsors and Collaborators
Medtronic Diabetes
Layout table for investigator information
Principal Investigator: Pratik Choudhary, MBBS, MRCP King's College London
Layout table for additonal information
Responsible Party: Medtronic Diabetes Identifier: NCT01726621    
Other Study ID Numbers: CEP267
First Posted: November 15, 2012    Key Record Dates
Results First Posted: April 18, 2016
Last Update Posted: April 18, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs