DTS BGMS Surveillance Program

“The availability of inaccurate BGMSs poses a public health problem...” Blood glucose monitoring systems (BGMS) are cleared by regulatory agencies on the basis of their performance during testing conducted by their manufacturers. However, after clearance there is uncertainty whether BGMS maintain the accuracy levels that were achieved in their initial studies. The availability of inaccurate BGMS poses a public health problem because their readings serve as a basis for treatment decisions that can be incorrect. Several articles in peer reviewed medical journals over the past few years have concluded that BGMS currently in the marketplace may not consistently provide accurate results in accordance with the regulatory standards that led to approval. Information about which BGMS do and do not perform adequately may be of interest to: 1) patients (people with diabetes) who wish to select high quality BGMS for managing diabetes; 2) healthcare professionals who wish to recommend high quality BGMS to their patients to help lead to the best decisions for treatment; 3) payers who wish to spend their money on the best performing products to maintain the health of covered patients; and the FDA (and other regulatory agencies outside the US) that are interested in receiving high quality information from reputable sources to inspire investigations and compliance efforts. There is no other program in the world like the DTS BGMS Surveillance Program for providing high quality detailed performance information about BGMS to these four interested parties.

Most BGMS are cleared in the US by FDA if they are shown by the manufacturer to meet standards which FDA uses. Over the past decade the standards have become more rigorous. Once a product is cleared by FDA, it is not retested unless there is evidence that there is a problem with the product. FDA reviews reports about devices and if there is evidence of poor performance of a product, this agency may take enforcement steps to see that any problem is corrected. Usually, FDA does not test cleared products or inspect factories unless there is a suspicion of a problem. There are so many different BGMSs (~80) on the market in the US and so few high quality validated signals to report their performance that it can be difficult for FDA to receive adequate information to know whether a product’s performance has begun to decline. Automatically mandated performance retesting after every one or two years would lead to regular retesting and might identify problems of declining performance. However, such automatic testing is not consistent with US law.

A BGMS postmarket surveillance program can provide high quality information to FDA of products that are performing poorly; FDA can then choose to investigate and take appropriate actions based on their investigations. Blood glucose monitoring systems are the most widely used device in the US and the device for which FDA receives the most complaints, so a surveillance program for this product can potentially obviate many complaints and device-associated complications.

Most BGMS for personal use in the US were cleared according to standards developed by the International Standards Organization (ISO) based in Switzerland. This century the ISO 15197 standards were updated in 2003 and again in 2013. FDA released a draft guidance containing standards for approval in January 2014 that are the most rigourous of these three. Many articles in peer reviewed journals since 2010 have looked at the performance of currently available BGMS. The conclusion in virtually every article is that most BGMS on the market (irregardless of when or where they were cleared) perform up to expected ISO 15197 standards, however approximately ¼ of BGMS do not perform up to 2003 ISO standards and approximately 1/2 of BGMS do not perform up to 2013 ISO standards. Since the ISO 15197: 2013 and FDA 2014 standards are similar, it would be expected that a similar percentage of BGMS would fail to meet the 2014 standards as failed to meet the 2013 standards.

Blood Glucose Monitoring System Surveillance Program