Roche has received FDA clearance for its Accu-Chek Combo system for insulin pump therapy. The Accu-Chek Combo combines a blood glucose meter with an insulin pump, which communicate with each other using Bluetooth wireless technology. The main advantage of the system is that the pump can be remotely operated by the meter, allowing for insulin administration without the need to touch the pump itself.

In addition, the Accu-Chek Combo system also features a full-color display that displays blood glucose data, insulin dose information and pump settings. There’s also a bolus advice function on the meter that calculates a recommended insulin bolus dose based on current blood sugar level, carbohydrate intake and, when applicable, exercise level, stress, illness and premenstrual status, which can then directly be administered from the meter. Customizable reminders can be set for changing infusion sets, making doctor and lab visits, retesting following meals and out-of-range blood glucose incidents.

The fine details of the pump include the ability to adjust the basal rate to as low as 0.05 units per hour in 0.01 unit increments, and an insulin cartridge that holds up to 315 units. The pump can also be operated independently from the meter whenever necessary and it is water-tight for up to 2.5 meters for 60 minutes, although Roche only guarantees protection against brief accidental water contact, such as rain, water splashes or accidental immersion. Ironically, although the meter and pump communicate amongst themselves using Bluetooth, the specifications for the devices only list good-old infrared interfaces for data transfer. The Accu-Chek Combo system has been launched already in several European and Asia-Pacific nations.

Press release: FDA clears Accu-Chek Combo system – Roche’s new interactive insulin pump system for people with diabetes…

Product page: ACCU-CHEK Combo System…