Roche Gains CE Mark For CGM

Roche announced that its Accu-Chek Smartguide continuous glucose monitor (CGM) has been awarded a CE certification.

In March, Roche presented its CGM gadget. The gadget is “more than just one sensor that generates the data,” Jochen Berchtold, Roche’s franchise head for insulin treatment solutions, told reporters this month. Instead, Accu-Chek Smartguide is defined as “a combination of digital assets with artificial intelligence (AI)-based predictive algorithms that actually support people.”

If patients connect with that appeal, Berchtold and his colleagues will find out. With the CE certification, Roche is able to offer its CGM device to adults over the age of 18 who are on flexible insulin treatment and have either Type 1 or Type 2 diabetes.

Roche presented a case study showing that some Type 1 diabetics failed to meet their glycemic control goals and experienced severe hypoglycemia episodes when using CGM systems. The research did point out that incidence of “diabetic ketoacidosis (DKA) and severe hypoglycemia were significantly higher in nonusers compared to CGM users,” and that overall, glycemic control was better in those who used CGMs.