, for insulin delivery in children and adults with diabetes.
The pump delivers insulin under the skin at a variable or fixed rate. It can function on its own, or it can be digitally connected to automatically communicate with and receive drug-dosing commands from other diabetes management devices, such as automated insulin-dosing systems, the agency announced.
The approval was based on a review of performance data demonstrating that the device can deliver insulin accurately and reliably and at the rates and volumes programmed by the user. The agency also assessed the pump’s ability to connect reliably with other devices, as well as its cybersecurity and fail-safe modes.
Risks associated with the device were similar to those of other infusion pumps and include infection, bleeding, pain, or skin irritations. Blockages and air bubbles can occur in the tubing, which will affect drug delivery. Risks associated with incorrect drug delivery include hypo- and hyperglycemia as well as diabetic ketoacidosis.
“The marketing authorization of the [pump] has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently,” FDA Commissioner Scott Gottlieb, MD, said in the announcement.