NCT01726621

User Evaluation of the MiniMed 620G and 640G Insulin Pumps

A User Evaluation of the MiniMed® 620G and 640G Insulin Pumps and Guardian® Link Transmitter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 7 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 1 Diabetes
• Type 2 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2012-11-15
• Last updated: 2016-04-18
• Results posted: 2016-04-18

Locations

6 sites across 4 countries: Australia, Denmark, Spain, United Kingdom