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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
55
Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks.
St Vincent Hospital and The University of Melbourne
Fitzroy, Australia
The Royal Melbourne Hospital
Patkville, Australia
Herlev Hospital
Herlev, Denmark
Barcelona University Hospital
Barcelona, Spain
University College Hospital
London, United Kingdom
King's College London
London, United Kingdom
User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter
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.
Time frame: Four weeks of pump wear
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