Sinocare iCan CGM System Receives CE Mark for Back Upper Arm Wear in People Aged 13+
Sinocare obtained CE Mark (EU 2017/745 Medical Device Regulation) for iCan continuous glucose monitoring system for use on the back upper arm of people living with diabetes aged 13 years and above. iCan CGM System now benefits from more body placement options than the market leader, providing additional user choice through multiple body placement options; arm and abdomen.
Underpinned by two significant multi-centre clinical studies performed in the United States of America(1)(2) and in Germany(1), the iCan CGM system showed a single digit MARD during the entire 15 days of accuracy measurement and an exceptional wear-life in both back upper arm placement and abdominal placement in adults and in adolescents aged 13 years and above.
These results using iCan on the back upper arm placement are consistent with those of the previous pediatric study from the age of 2 years, and the 18+ adult population studies(2)(3)(4) and fully complement the current iCan CGM approvals.
'We are delighted to bring the advanced and accurate iCan CGM system to children and adults in Europe. This CE Mark for the use of the iCan CGM on the back upper arm placement from age 13 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 iCan™️ CGM System
Sinocare iCan CGM System is one of the most widely clinically studied continuous glucose monitoring systems in the world.1, 2, 3, 4, 5
More than 500 people with type 1 and type 2 diabetes have participated in our world-wide clinical studies, and most clinical study participants have been assessed at sites in either the United States of America or in the Federal Republic of Germany.
~ 60.95% of 507 worldwide iCan CGM system clinical study subjects are people living with diabetes in either the USA or in Germany.
iCan CGM clinical study citations
1. Enrolment n=159 https://clinicaltrials.gov/study/NCT05806554 a completed study in adults.
2. Enrolment n=134 https://clinicaltrials.gov/study/NCT05908448 a completed study in children.
3. Enrolment n=78 https://clinicaltrials.gov/study/NCT06570551 a completed study in children.
4. Enrolment n=16 https://clinicaltrials.gov/study/NCT05348928 a completed study in adults.
5. Enrolment n=120 https://clinicaltrials.gov/study/NCT05995756 a completed study in adults.
About Sinocare Inc.
Sinocare is the largest manufacturer of glucose monitoring devices in Asia. Founded in 2002, Sinocare Inc. was the first blood glucose meter company to be listed in China. With a commercial presence in Asia, Europe and North America, Sinocare has expanded internationally through partnerships and acquisitions such as the USA based PTS Diagnostics Inc., Nipro Diagnostic Inc., now known as Trividia Health Inc. Its dedication to innovation in biosensing technology has helped Sinocare become the global 4th largest blood glucose meter manufacturer and one of the leading POCT companies worldwide.
For more inquiries, please contact:
Sinocare Inc. Investor Relations Office
Email: investor@sinocare.com
Phone: +86 0731-89935529
Website: www.sinocare.com