Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A Joint Statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

Lutz Heinemann, G. Alexander Fleming, John R. Petrie, Reinhard W. Holl, Richard M. Bergenstal, Anne L. Peters
2015 Diabetologia  
Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern in-to help healthcare teams to educate and support users, and thereby prevent AEs. As well as requiring more from the manufacturing companies, we call for public funding of more research addressing clinically important questions in relation to pump therapy: both observational
more » ... dies and clinical trials. At present there are significant differences in the regulatory systems between the USA and European Union at both preand post-marketing stages; improvements in the European system are more urgently required. This statement concludes with a series of recommended specific actions for 'meknovigilance' (i.e. a standardised safety approach to technology) which could be implemented to address the shortcomings we highlight.
doi:10.1007/s00125-015-3513-z pmid:25784563 fatcat:efyzwqdaavdkvoav72jqkyfrie