Abstract
INTRODUCTION: A new insulin pump system was tested under everyday conditions for user evaluation and safety assessment prior to its launch in Europe. This insulin pump is focused on easy handling and uses prefilled cartridges. METHODS: The pump system was used by 35 adult subjects with type 1 diabetes, experienced in insulin pump therapy, under everyday conditions for approximately one month each. All subjects rated various aspects of the system after home use; technical issues and safety parameters were assessed throughout the study. RESULTS: All 35 subjects completed the study as planned and used the system for a total of 1013 days. After home use, 74% of the subjects were very satisfied or quite satisfied with the new pump. The subjects confirmed that the system is easy to use, especially considering general handling, bolus delivery and basal rate settings, infusion set, and cartridge change. Potential for improvements was seen in the touchscreen, warnings and alarms, the blind bolus function, the availability of a bolus calculator (was not available at time of study), and the cartridge size as rated by the study participants. Safety analysis did not raise any concerns for the use of this system. CONCLUSION: The majority of the users testing the system were satisfied with the novel insulin pump system and the system was safe for use under everyday conditions by this study population.