User Evaluation of the MiniMed 620G and 640G Insulin Pumps
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.
|Type 1 Diabetes Type 2 Diabetes||Device: Medtronic MiniMed 620G or 640G Insulin Pump|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A User Evaluation of the MiniMed® 620G and 640G Insulin Pumps and Guardian® Link Transmitter|
- 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.
|Study Start Date:||March 2013|
|Study Completion Date:||December 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726621
|St Vincent Hospital and The University of Melbourne|
|Fitzroy, Australia, 3065|
|The Royal Melbourne Hospital|
|Patkville, Australia, 3050|
|Barcelona University Hospital|
|Barcelona, Spain, 08036|
|University College Hospital|
|London, United Kingdom, NW1 2PG|
|King's College London|
|London, United Kingdom, SE5 9NU|
|Principal Investigator:||Pratik Choudhary, MBBS, MRCP||King's College London|