ADA publishes statement on insulin pump safety
The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) has issued a clinical appraisal of insulin pump safety standards.
The introduction of insulin pumps has been one of the greatest advances in type 1 diabetes treatment history. Insulin pumps are now commonly used in the treatment of type 1 diabetes and are also being considered and used in some people with gestational diabetes and type 2 diabetes. Despite being commonly used, however, there are areas related to safety which could and should be improved according to the joint statement.
Whilst insulin pump manufacturers have taken care to ensure a strong level of safety, problems that can and do occur in a home usage setting include adverse events such as insufficient or excessive insulin delivery which can occasionally lead to dangerous short terms complications such as ketoacidosis and severe hypoglycemia.
Room for improvement in safety
Within the clinical appraisal, the ADA and EASD note a number of recommendations towards improving insulin pump safety.
The recommendations, which cover a wide range of stakeholders, from manufacturers to regulators to healthcare professionals, include:
- Bringing together American and European standards to be met by insulin pump manufacturers both before and after insulin pumps are launched.
- The European and US regulators should maintain a single publicly accessible database for reporting of adverse events.
- Pump manufacturers should provide more transparency in terms of data including how many people use their pumps, how durable and precise the pumps are and data related to product recalls.
- National and international societies should set guidelines on indications for insulin pump usage, education for insulin pump usage and standards for healthcare professionals that are responsible for overseeing care of patients on insulin pump therapy.
- Research funding bodies should facilitate funding of independent trials to determine insulin pump effectiveness and safety within a real-world setting.
- Healthcare teams responsible for patients on insulin pumps should provide regular structured training for patients and should encourage patients to report all adverse events related to insulin pump usage.
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