User Evaluation of the MiniMed 620G Insulin Pump
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 Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A User Evaluation of the MiniMed® 620G Insulin Pump and Guardian® Link Transmitter|
- Does user acceptance of the new MiniMed 620G insulin pump and Guardian Link transmitter meet expectations? [ Time Frame: Four weeks of pump wear ] [ Designated as safety issue: Yes ]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 and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.
- Do the training materials provided with the products meet the needs of the participants? [ Time Frame: One month ] [ Designated as safety issue: No ]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 subject acceptance of the training materials. A response of 4 or greater on the Likert scale will be considered positive for the training materials and indicate acceptance.
|Study Start Date:||January 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Insulin dependent diabetics
Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G insulin pump and Guardian Link transmitter
Device: Medtronic MiniMed 620G Insulin Pump
Subjects to use the Medtronic MiniMed 620G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks.
|St Vincent Hospital and The University of Melbourne||Not yet recruiting|
|Fitzroy, Australia, 3065|
|Principal Investigator: David O'Neal|
|The Royal Melbourne Hospital||Not yet recruiting|
|Patkville, Australia, 3050|
|Principal Investigator: Peter Colman|
|Herlev Hospital||Not yet recruiting|
|Contact: Lise Frost|
|Principal Investigator: Birthe Susanne Olsen|
|Barcelona University Hospital||Not yet recruiting|
|Barcelona, Spain, 08036|
|Contact: Xavier Navarro|
|Principal Investigator: Ignacio Conget|
|King's College London||Not yet recruiting|
|London, United Kingdom, SE5 9NU|
|Contact: Sharon Reid|
|Principal Investigator: Pratik Choudhary, MBBS, MRCP|
|University College Hospital||Not yet recruiting|
|London, United Kingdom, NW1 2PG|
|Contact: Sharon Reid|
|Principal Investigator: Peter Hindmarsh|
|Principal Investigator:||Pratik Choudhary, MBBS, MRCP||King's College London|