Biotech titan Roche secured a landmark FDA win with clearance for its Accu-Chek Aviva Expert blood glucose meter, the 1st of its kind with a built-in insulin calculator to help guide patient therapy.
A significant portion of the 6 million estimated diabetics in the U.S. use multiple daily injections of insulin to manage their disease. These patients must obtain regular blood glucose readings and perform sometimes complex calculations to determine the appropriate amount of insulin to inject.
Inappropriate doses can lead to over- or under-dosage, putting patients at risk for serious complications, Roche said.
"A multicenter study found that 63% of manually calculated insulin doses were incorrect," the company noted. "Researchers from the U.S. Centers for Disease Control & Prevention reported that there were nearly 100,000 emergency room visits each year between 2007 and 2011 that were attributed to insulin-related hypoglycemia and other errors, and that these visits accounted for roughly 9& of all ER visits due to drug reactions during this timeframe."
The new Accu-Chek system, available by prescription only to patients trained in insulin self-injections, consists of the Aviva Expert meter, Aviva Plus test strips, Aviva control solutions and Bolus Advisor. The system captures blood glucose levels via finger-prick blood samples and combines that data with patient-entered carbohydrate intake to provide an insulin dosage recommendation based on a physician-determined target blood glucose level.
"We are excited to provide the diabetes community with this innovative solution that will allow users to accurately calculate their insulin dose," Roche Diabetes Care North American head Marc Gibeley said in prepared remarks. "The ACCU-CHEK Aviva Expert system is the first and only system of its kind that provides meal and correction insulin bolus recommendations, which can help patients on insulin therapy have the confidence they need to better manage their diabetes."