Grassroots innovation: How a patient-driven device for diabetes won FDA clearance

Grassroots innovation: How a patient-driven device for diabetes won FDA clearance

Tidepool Loop, an automated insulin dosing app based on one developed by the DIY diabetes community, received FDA clearance in January. Diabetes sufferers and researchers have been collaborating for years to create an artificial pancreas that can monitor blood sugar levels and deliver insulin as necessary. In the multibillion-dollar market for diabetic devices, those efforts have resulted in the production of the first hybrid closed-loop systems, where continuous glucose monitors and insulin pumps collaborate. These methods nevertheless have certain drawbacks. For starters, since the software that enables the two devices to function together is now built into insulin pumps, patients cannot pick and choose which devices they want to connect together. The regulatory landscape for clinical decision-making software is intricate. Take control of the chaos with the help of this webinar featuring Advarra's device research expertise.




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