Roche plans to launch its first continuous glucose monitor (CGM) in Europe “in the coming weeks,” Sérgio Moreiras, the company’s international business leader for continuous monitoring, said on Tuesday.
The company received a CE mark in July for the Accu-Chek Smartguide, authorizing the device for people ages 18 and up with Type 1 or Type 2 diabetes. Roche will roll out the CGM in the Netherlands, Switzerland and Germany, Moreiras said at the European Association for the Study of Diabetes annual meeting in Madrid.
Accu-Chek Smartguide can be worn for 14 days, and features predictive algorithms that Roche hopes will differentiate it from competitors Abbott and Dexcom. However, it also must be calibrated at first using a finger stick, which some of the newest CGMs do not require.
More than 40% of people with Type 1 diabetes have a hypoglycemia event during the night, while people with Type 2 diabetes experience an average of 23 hypoglycemic events throughout the year, Moreiras said.
“Clearly, the hypoglycemia fear was something that we felt that had to be addressed when we were going towards building our solution,” he said.
Roche developed the CGM with three different prediction tools: A feature to predict the risk of low blood glucose within 30 minutes, a feature to forecast glucose levels over the next two hours, and a feature to predict hypoglycemia risk at night.
Pau Herrero, an algorithm and decision support tech lead at Roche, said the device provides a different picture than the trend arrows other CGMs use, which typically forecast glucose levels over the next 20 minutes. The predictions are based on multiple days of patient data using machine learning models.
“There are so many factors affecting your glucose, the variability is huge. Almost every day is different, so it’s a very complex problem,” Herrero said.
Roche tested the algorithms on three different datasets that included people with Type 1 and Type 2 diabetes, taking insulin shots or using an insulin pump. Accu-Chek Smartguide was able to predict low glucose levels within 30 minutes with 95% sensitivity and 99% specificity. The feature for predicting nighttime lows detected about 77% of events.
The company is in “active discussions” with the Food and Drug Administration on bringing Accu-Chek Smartguide to the U.S., Moreiras said, adding that he “cannot commit to any timelines.”
Moreiras also did not provide timing for a pediatric indication for the CGM.
In March, Roche shared results of a 48-person, open-label trial of the new CGM. The mean absolute relative difference (MARD) between the CGM readings and capillary blood glucose values was 9.2%. By comparison, Dexcom’s G7 CGM has a MARD of 8.2%, and Abbott’s Freestyle Libre 3 has a MARD of 7.8%. A lower MARD indicates more accurate readings.
Roche intends to add other features, including integration with the company’s MySugr app and further algorithms. The company also is looking into next generation sensors on the hardware side.