FDA clears 1st automated device for Type 2 diabetes

The FDA has expanded the indications for Insulet SmartAdjust technology to include the management of Type 2 diabetes in people 18 and older.

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Insulet SmartAdjust is an interoperable, automated glycemic control software that connects to an insulin pump and continuous glucose monitor to automatically adjust insulin delivery. The technology was previously approved only for management of Type 1 diabetes, according to an Aug. 26 news release from the FDA.

Individuals with Type 2 diabetes typically manage insulin levels by manually checking blood glucose levels and self-administering insulin one or more times a day. 

The Insulet SmartAdjust technology was cleared through the FDA’s 510(k) premarket pathway.

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