Roche wins CE mark for its first CGM

Roche has received a CE mark for its Accu-Chek Smartguide continuous glucose monitor (CGM), enabling it to compete with Abbott and Dexcom in the European market. Roche plans to start sales "in selected European markets in the coming months." The device uses advanced algorithms to predict glucose levels, aiding proactive health management. Roche’s insulin therapy solutions lead, describes it as combining digital assets with AI-based predictive algorithms.

The CE mark permits Roche to offer the CGM to individuals over 18 with Type 1 and Type 2 diabetes on flexible insulin therapy. Roche claims the device can address persistent glycemic control issues, supported by a study showing better overall glycemic control with CGM users. The device predicts hypoglycemia risk and glucose changes, potentially reducing hypoglycemia distress.

Analysts from BTIG and J.P. Morgan question its market impact, noting the need for finger stick calibration as a possible barrier to adoption.