Ascensia Diabetes Care announced the commercial launch and U.S. Food and Drug Administration (FDA) approval of its new blood glucose monitoring system Contour Next Link 2.4 for diabetes treatment management.
“We are delighted that the MiniMed 630G system with the Contour Next Link 2.4 meter will now be available to people with diabetes in the United States,” Robert Schumm, president of the company in the U.S., said in a press release. “The accuracy of our blood glucose monitoring system combined with the new innovative technology of the MiniMed 630G system will truly help people with diabetes manage their condition.”
Findings from a lab study showed that 99% of the results obtained with the new product were within an average of 10 mg/dL or 10% of the YSI (yellow spring instrument) reference results for samples with glucose concentrations lower than 100 mg/dL and equal or higher than 100 mg/dL, respectively.
The results were previously presented at the 7th International Conference on Advanced Technologies & Treatments for Diabetes in 2014 and published later in an article titled “Accuracy and user performance evaluation of the Contour Next Link 2.4 blood glucose monitoring system.”
The product is part of the Medtronic MiniMed 630G system, an integrated insulin pump with continuous glucose monitoring (CGM) developed with the company’s SmartGuard technology. The new product sends data wirelessly on blood glucose levels for CGM calibration and insulin dosing. The process eliminates manual entry errors that often result in an incorrect bolus (dose) calculation. The device also gives patients a discrete way to give a bolus of insulin remotely from the meter to the pump which adds to the product’s easy convenience.
MiniMed 630G additionally triggers an alarm to alert users when the sensor detects low blood sugar levels. The device suspends insulin delivery if the user is immediately unresponsive to such alarm.
“Meter accuracy is particularly important for insulin pump users with regard to CGM calibration and insulin bolus calculations. The launch of the Contour Next Link 2.4 meter as part of the MiniMed 630G system means people with diabetes in the U.S. now have access to highly accurate blood glucose monitoring, with the latest advancements in fully integrated insulin pumps” Schumm concluded.