Sinocare obtained CE Mark (EU 2017/745 Medical Device Regulation) for iCan continuous glucose monitoring system for children aged from 2 years to 17 years of age with diabetes.

Underpinned by a significant multi-centre clinical study within three major pediatric diabetes hospitals ⁽¹⁾, the iCan CGM system showed exceptional wear-life and a single digit MARD during the entire 15 days of accuracy measurement.    

The results of the pediatric study are consistent with those of the previous 18+ population studies ^{(2) (3) (4)}, complementing the current adult iCan CGM approval.

'We are delighted to bring the innovative and accurate iCan CGM system to children and adults in Europe. This CE Mark for the use of the iCan CGM from age 2+ means broader access to continuous glucose monitoring for all people, regardless of age, race and affordability', commented Dr Jiangfeng Fei, global Head of Sinocare CGM business unit.

About Sinocare 

Founded in 2002, Sinocare Inc. was the first blood glucose meter company to be listed in China. With a strong presence in Asia and the U.S., Sinocare is the largest manufacturer of blood glucose monitoring devices in Asia and the fourth largest globally, as well as one of the leading POCT companies worldwide.  It continues to lead the way in biosensing innovation on the international stage, advancing its mission to be the global leading diabetes digital management expert.

*For safety reasons, CGM insertion must be performed by a caregiver for children 2 to 11 years of age and the caregiver should always carry a mobile phone connected to the CGM.

Clinical trial references

(1)  

(2)  

(3)  

(4)  LINONG JI, FRANK FLACKE, FEI GAO, YUANYUAN YU, JIYUN ZHENG, AO GAO, JIANGFENG FEI; 987-P: iCan CGM System—Performance Evaluation of a New CGM System with an Innovative Sensor Technology. Diabetes 14 June 2024; 73 (Supplement_1): 987–P.

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