User Evaluation of the MiniMed 640G Insulin Pump
|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.|
|ClinicalTrials.gov Identifier: NCT01991548|
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Type 2 Diabetes||Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A User Evaluation of the MiniMed® 640G Insulin Pump and Guardian® Link Transmitter|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
|Diabetic participants with study devices||
Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter
- User Acceptance of the New MiniMed 640G Insulin Pump 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 subject acceptance of the MiniMed 640G, Guardian Link Transmitter, and the training materials. A response of 4 or greater will be considered positive on a Likert scale for training materials and product acceptance.
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 ClinicalTrials.gov identifier (NCT number): 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|