User Evaluation of the MiniMed 640G Insulin Pump
Recruitment status was: Not yet recruiting
This four center international study will include two United Kingdom National Health Service centers, and two centers in Melbourne, Australia. The objective of the study is to evaluate subject acceptance of 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 four 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
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A User Evaluation of the MiniMed® 640G Insulin Pump and Guardian® Link Transmitter|
- Likert scale [ 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 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:||November 2013|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01991548
|St Vincent Hospital and The University of Melbourne|
|Fitzroy, Australia, 3050|
|The Royal Melbourne Hospital|
|Patkville, Australia, 3050|
|University College Hospital|
|London, United Kingdom, NW1 2PG|
|King's College London|
|London, United Kingdom, SE5 9NU|