Dive Brief:
- Roche said Tuesday it has received a CE mark for its Accu-Chek Smartguide continuous glucose monitor (CGM).
- The clearance positions Roche to challenge Abbott and Dexcom for the European CGM market. Roche plans to start selling the device “in selected European markets in the coming months.”
- Facing well-established incumbents, Roche is emphasizing the device’s algorithms for predicting glucose levels as a differentiator that could empower users to proactively manage their health.
Dive Insight:
Roche unveiled its CGM device in March. Jochen Berchtold, Roche’s franchise lead for insulin therapy solutions, told reporters that month the device is “more than just one sensor that generates the data.” Rather, Accu-Chek Smartguide is “a combination of digital assets with AI-based predictive algorithms that really support people.”
Berchtold and his colleagues will find out whether that pitch resonates with patients. The CE mark clears Roche to provide its CGM device to people with Type 1 and Type 2 diabetes over the age of 18 on flexible insulin therapy.
Roche is yet to say exactly when and where it will launch the device.
The company is pitching Accu-Chek Smartguide as a device that can address glycemic control problems that persist even when using other CGM devices.
Roche cited an observational study that found some people with Type 1 diabetes missed glycemic control targets and had severe hypoglycemia events using CGM devices. However, the study noted that CGM users had better glycemic control overall and rates of “diabetic ketoacidosis (DKA) and severe hypoglycemia were significantly higher in nonusers compared to CGM users.”
Roche’s algorithms assess the risk of hypoglycemia over the next 30 minutes, predict how glucose levels will change in the next two hours and estimate the chances of nocturnal hypoglycemia. The company has generated evidence that two-hour predictions can reduce distress and fear of hypoglycemia.
Wall Street analysts have questioned whether Roche can gain ground in the market. When Roche unveiled the device, BTIG and J.P. Morgan analysts said Accu-Chek Smartguide is unlikely to pose a major threat to Abbott and Dexcom. The analysts identified the need to calibrate Roche’s device with a finger stick as a barrier to uptake.
Correction: In a previous version of this article, the day the announcement was made was incorrect. The announcement was made Tuesday.