USA Vs Europe: Who Is Leading the Diabetes Tech Race?
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Purpose of Review
To highlight global advancements in diabetes technology and compare available technologies and device approval processes in the USA and Europe and their impact on safety and innovation.
The last two decades have seen a rapid growth in diabetes technology driven by the impetus to improve glycemic control, avoid complications of insulin therapy, improve quality of life, and hand more autonomy to individuals with diabetes. Meanwhile, changes to regulatory processes in the USA and Europe aim to facilitate entry of new devices into the marketplace.
Major strides have been made in digitization of insulin pens, continuous glucose monitors and their integration with insulin pumps, automated insulin delivery systems, and closed-loop insulin pump systems. The centralized regulatory body in the USA and more decentralized approval bodies in Europe have led to differences in the rate of market availability of diabetes devices. While both US and Europe systems have different advantages and disadvantages in device approval, they continue to struggle with balancing accelerated device access with adequate clinical evidence and monitoring to ensure safety of such devices.
KeywordsDiabetes technology Europe United States Insulin pump Continuous glucose monitor Approval process
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they have no conflicts of interest.
Human/Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
Papers of particular interest, published recently, have been highlighted as: •• Of major importance
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