European Data of a US and European Pivotal Study of iCan i3 CGM

Sinocare Meditech Inc., is pleased to highlight recently published clinical data with iCan i3 continuous glucose monitoring system. A single center analysis was developed with the intention of providing European data from the highest-enrolling center, Ulm Germany, of a US and European pivotal study of i3 CGM assessed under iCGM special controls.

The iCan CGM System delivered 20/20 agreement rates of 95.5% (abdominal placed sensors) and 20/20 95.3% (arm worn sensors). Consensus error grid (CEG) analyses revealed that 100% of CGM-comparator pairs fell in zones A and B for both arm and abdomen sensors.

Data collected showed robust point accuracy results, which simultaneously fulfilled the iCGM special controls criteria.

Adhesion rate was 100% for abdomen sensors and 97.1% for arm-worn sensors, without the use of any over-tape during the 15-day study period.

iCan i3 CGM showed reliability, and its safety was validated during the 15 study days.

The study may be found at ClinicalTrials.gov (ID: NCT05806554).

The publication may be found at Diabetes Therapy https://doi.org/10.1007/s13300-025-01832-6

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

Enrolment n=159 https://clinicaltrials.gov/study/NCT05806554 a completed study in adults.

Enrolment n=134 https://clinicaltrials.gov/study/NCT05908448 a completed study in children.

Enrolment n=78 https://clinicaltrials.gov/study/NCT06570551 a completed study in children.

Enrolment n=16 https://clinicaltrials.gov/study/NCT05348928 a completed study in adults.

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.

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Sinocare Inc. Investor Relations Office

Email: investor@sinocare.com

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