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

Abstract

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 insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycaemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycaemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilised due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices, EUDAMED) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to 'predicate' products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real-world setting; such data could provide vital information Diabetologia (2015) 58:862-870 DOI 10.1007 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 studies 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.

Clinical review: insulin pump-associated adverse events in adults and children

“…As we move forward, it is important for professionals and patients to have a thorough understanding of insulin pump-associated adverse events in all their forms, and more research is needed to fully understand this aspect of CSII therapy. In addition, as recently recommended [48], pre-and post-marketing surveillance for adverse events should be transparent, appropriately categorised, and promoted for both manufacturers and consumers.…”

Adhesives Used for Diabetes Medical Devices

“…In practice, our own attempts to analyze the FDA database (the EU database is not openly accessible) showed that the data stored represent a meaningless mess. 11 What is the reason for skin reactions, especially for contact dermatitis? Detailed information about adhesives is not readily available, especially regarding which materials are used in them.…”

Reducing glucose variability with continuous subcutaneous insulin infusion increases endothelial progenitor cells in type 1 diabetes: an observational study

“…Although both CSII and MDI therapy are recommended treatment strategy for type 1 diabetic patients [9], CSII is more effective than MDI in reducing glucose variability [10,11]. Furthermore, a recent joint statement by ADA and EASD Diabetes Technology Working group [30] calls for an appropriate selection of candidates for pump therapy. As a corollary, the willingness to use an insulin pump by a Endocrine potential candidate is a necessary prerequisite.…”