USA Vs Europe: Who Is Leading the Diabetes Tech Race?
| Autor: | Archana R. Sadhu, Abhishek Kansara, Ashkan Zand, Spandana Brown, Gonzalo Acosta |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Insulin pump Adult Blood Glucose Device Approval Endocrinology Diabetes and Metabolism media_common.quotation_subject medicine.medical_treatment 030209 endocrinology & metabolism 03 medical and health sciences 0302 clinical medicine Quality of life (healthcare) Insulin Infusion Systems Inventions Diabetes mellitus Internal Medicine medicine Diabetes Mellitus Humans Hypoglycemic Agents Insulin Operations management media_common Glycemic business.industry Blood Glucose Self-Monitoring medicine.disease United States Europe 030104 developmental biology Patient Safety Glucose monitors business Autonomy |
| Zdroj: | Current diabetes reports. 19(11) |
| ISSN: | 1539-0829 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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