[Edaily Reporter Kwon Oh-seok] Laser healthcare specialist #Lameditech announced on the 9th that the results of a clinical study on its laser blood-lancing blood glucose meter, ‘HandyRay-Glu,’ have been published in ‘Diagnostics,’ an international academic journal in the field of medical diagnostics.

The company explained that this publication officially recognizes that its laser blood glucose monitoring system—which significantly reduces the pain associated with “needle pricks,” the aspect of blood testing that diabetes patients find most uncomfortable—has achieved accuracy and clinical utility that meet international standards.
This study was conducted by a research team from the Department of Endocrinology and the Department of Laboratory Medicine at Korea University Ansan Hospital, involving 100 diabetes patients. The researchers verified the analytical performance and clinical accuracy of HandyRay-Glu in accordance with ISO 15197:2013, the international standard for evaluating the performance of self-monitoring blood glucose meters.
The study compared blood glucose values measured by HandyRay-Glucose with results from the Roche ‘cobas c111,’ a global standard analytical instrument. The results showed that 97.8% of HandyRay-Glucose’s measurements met the accuracy criteria required by ISO 15197:2013, exceeding the minimum required level of 95%. In the correlation analysis, the Pearson correlation coefficient (r) was recorded at 0.992, demonstrating a level of agreement virtually equivalent to that of the standard device. Furthermore, the deviation was found to be minimal, confirming the absence of systematic error.
The results of the “Clarke Error Grid” analysis, which assesses the likelihood of misdiagnosis in actual clinical settings, were also positive. HandyRay-Glue’s measurements were 100% distributed across Zones A and B—classified as having no risk of misdiagnosis—and were evaluated as yielding clinically reliable data.
Unlike conventional lancet-based blood sampling, which involves pricking the fingertip with a metal needle, HandyRay-Glue is an all-in-one device that uses a laser to create a tiny hole in the skin and then collects a small amount of blood to measure blood glucose levels. It is designed to provide necessary blood glucose information while reducing the pain, skin damage, and psychological burden caused by repeated fingerstick sampling.
Evaluations of its ease of use are also positive. In a survey conducted during the clinical trial, 99.0% of respondents reported that the HandyRay-Glue user manual was easy to understand and that the measurement results were easy to read, while overall satisfaction reached 97.0%, confirming its competitiveness in terms of real-world usability from the patient’s perspective.
A representative from Lameditech stated, “While blood glucose monitoring is a daily essential management task for diabetes patients, the method of pricking the fingertip with a needle has historically led to avoidance of testing or extended intervals due to pain and fear.” They added, “HandyRay-Glue is significant because it reduces this burden through laser blood collection technology while also having its accuracy verified in international academic journals.”
The representative added, “We plan to further enhance user convenience by improving blood glucose recording and management features through a dedicated app, and we aim to develop this into a personalized blood glucose management solution based on digital health in the future.”