7. Drug & Device Updates

FDA approves Qternmet XR

The Food and Drug Administration (FDA) has approved Qternmet XR from AstraZeneca as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Qternmet XR is a combination product that contains dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin, a biguanide. Initiation with Qternmet XR is intended only for patients currently taking metformin. The approval was based on data from two phase 3 trials which evaluated combinations of dapagliflozin and saxagliptin on a background of metformin over 24 weeks, in patients with inadequately-controlled T2D.

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FDA Warning on Do-It-Yourself Artificial Pancreas

The U.S. Food and Drug Administration warned diabetes patients against building their own artificial pancreas system after a patient using DIY automated insulin dosing systems suffered an accidental insulin overdose. According to the FDA, someone who utilized a self-constructed automated insulin pump system received too much insulin from their insulin pump. They were using a pump and continuous glucose monitor (CGM) which had not been tested by the agency for compatibility, according to the notice. The DIY artificial pancreas movement began when the early pioneers of the movement were frustrated with the perceived lack of progress in the development of FDA-approved automated insulin pump systems. What was initially perceived as a fringe medical movement has moved closer to the mainstream in recent years, as several companies, have been attempting to develop projects inspired by DIY automated insulin dosing systems or algorithms for FDA approval.

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