FDA clears Accu-Chek Combo, a blood-glucose meter and insulin pump device

INDIANAPOLIS — Roche on Wednesday announced that it has received clearance from the Food and Drug Administration for its Accu-Chek Combo system for insulin pump therapy.

The Accu-Chek Combo system seamlessly combines a blood-glucose meter with an insulin pump, which are able to exchange data in both directions via Bluetooth wireless technology. The meter not only enables the user to quickly test blood-glucose levels, it allows users to remotely operate the insulin pump, and by means of an easy-to-handle bolus adviser, it provides support in defining the right amount of insulin. With this, the Accu-Chek Combo system not only supports a more targeted therapy management, but it also allows for a discreet insulin administration without the need to touch the pump, the company stated.

"The Accu-Chek Combo system clearly demonstrates Roche's dedication to integrated diabetes management solutions, combining the technical components for blood-glucose monitoring, data management and insulin delivery," said Luc Vierstraete, head of Roche Diabetes Care. "This new system is designed to support insulin pump patients in managing diabetes easily and discreetly in their everyday life."

"With this clearance we are now looking forward to launch the second device in the U.S. this year, after the successful clearance of the Accu-Chek Nano SmartView system in the first quarter. Both launches represent a significant milestone for our Diabetes Care business," said Daniel O' Day, chief operating officer Roche Diagnostics.

The Accu-Chek Combo system also features:

  • A full-color display that brings to life blood-glucose data, insulin dose information and pump settings;

  • Flexibility to adjust the basal rate to as low as 0.05 units per hour — in increments as precise as 0.01 units; and

  • An insulin cartridge that holds up to 315 units of insulin, one of the largest capacities among pumps sold in the U.S.


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