By Kang Seung-woo
As diabetes patients currently reach roughly 5 million, demands for devices that aid in the self monitoring of blood glucose (SMBG) are increasing. The significance of a self blood glucose management meter’s accuracy is significant to evaluate the performance of the medical device.
After a great number of trials and testing over a considerable period, Johnson & Johnson, the largest SMBG seller worldwide, is well-prepared to provide authentic monitoring.
SMBG helps patients and healthcare professionals select the appropriate treatment by analyzing the patients’ blood glucose levels in a timely fashion.
The size of the local SMBG market is estimated to be over 60 to 70 billion won ($55.14 million to $64.33 million) and it is expected that the market will be even larger after July this year because patients of SMBG of type 1 diabetes mellitus, which is known as juvenile diabetes, will starting then, be able to receive reimbursements from the National Health Insurance Corp. (NHIC).
However, proper awareness and understanding of the importance of SMBG accuracy still appears to be lacking.
According to a local trade media report, SMBG meters often show incorrect results with errors averaging 20 to 30 milligrams/deciliters, sometimes even 100 milligrams/ deciliters. SMBG inaccuracy may lead patients to suffer convulsions, comas and even death without proper and timely treatment especially for hypoglycemia. Trade media added that developed countries including the European Union (EU) are demanding higher accuracy standards for SMBG meters.
U.S. FDA requested the International Standard for Organization (ISO) to regulate and improve SMBG meter accuracy in 2009. The agency said that the inaccuracy ratio of current SMBG meters reached as high as 20 percent due to loosened ISO standards. And some global major manufacturers promptly responded to the agency.
New Jersey-based Johnson & Johnson had already conformed to ISO standards for the past seven or eight years and continue to strengthen its products’ accuracy.
The company has accumulated the largest amount of clinical data on the accuracy of their SMBG meters with the testing of over 70,000 patients during the past eight years. This has proven its one touch products’ accuracy exceeding ISO standards.
Abbott, another global pharmaceuticals health care company, also said that it plans to participate in the international evaluation of SMBG accuracy standards as well.
“SMBG meters must provide accurate blood glucose levels using advanced technologies and long-time verification. SMBG meters, different from other meters like weighing scales, are undoubtedly medical devices that claim accuracy as foremost selection criteria,” said an industry source.