Roche plans to roll out its Accu-Chek Smartguide in the Netherlands, Switzerland and Germany in the coming weeks.
The company received a CE mark in July for the Smartguide, authorizing use of the device by people ages 18 and up with Type 1 or Type 2 diabetes. It can be worn for 14 days and the company hopes it will stand out from competitors with its three predictive 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 hypoglycaemia 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.
Roche tested the algorithms on three different datasets that included people with Type 1 and Type 2 diabetes, and claim that the Accu-Chek Smartguide could 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 also in ‘active discussions’ with America’s Food and Drug Administration (FDA) on bringing Accu-Chek Smartguide to the US.
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