Not All Blood Glucose Monitors Effectively Help Manage Diabetes

Despite FDA approval, many devices vary in their ability to accurately monitor blood glucose levels for diabetes patients, according to a session at the American Association of Diabetes Educators 2017 Annual Meeting.

During his presentation, David Klonoff, MD, medical director at the Diabetes Research Institute at Mills-Peninsula Medical Center in California, presented research from his study “the Surveillance Program for Cleared Blood Glucose Monitor Systems.” During the study, researchers examined the efficacy of 18 different FDA-approved blood glucose monitors. They compared their results against the current ISO standards in order to determine efficacy. 

Dr Klonoff explained that the accuracy of approved devices can degrade over time.

“One might assume that any medical product that has been cleared by the FDA will continuously perform at the level for which it was cleared or at the level claimed by the manufacturer at the time of clearance,” he said in a press release.  “This is not necessarily the case for some products. Be a cautious informed clinician, consumer, and payer when it comes to medical devices that depend on delivering a level of accuracy.”

During his presentation, Dr Klonoff explained that glucose monitors can experience analytical errors for a variety of reasons. User error, including use of expired strips, use of improperly stored strips, and unclean hands, can cause these errors. Furthermore, he explained that interfering substances in the physical environment such as humidity, can also cause errors. 

Other errors occur because certain monitors are not user friendly. These devices can prompt users with misleading messages, shut off automatically when blood glucose levels are high, or fail to transmit data correctly. 

Dr Klonoff stressed that technology  works best when is accurate and secure. He pointed to a number of cybersecurity flaws that could also cause issues  with network connected devices. Security flaws leave patient data open to privacy breache, he explained.

In a separate session, Adam Brown, senior editor at diaTribe, noted that user error can sometimes be to blame for ineffective use of continuous blood glucose monitoring devices. 

He said that when calibrating continuous blood glucose monitoring devices, patients must remember to wash their hands and enter the blood glucose reading immediately after taking the
test in order to keep the devices as accurate as possible. —David Costill