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FDA Orders Recall of Drug Dosage mHealth App for Diabetic Patients

The FDA has ordered the recall of an mHealth app that helps people with diabetes determine how much insulin they should inject. The issue points to the continuing challenge of verifying the accuracy of digital health devices and drug dosage apps.

Source: ThinkStock

By Eric Wicklund

- Federal authorities have issued a recall for an mHealth app that could cause people with diabetes to administer incorrect doses of insulin, potentially putting them at risk of death.

The U.S. Food and Drug Administration has issued a Class 2 device recall for the Accu-Check Connect diabetes management app developed by Roche. Company officials say more than 67,000 people are using the pp.

According to Roche officials, a bug in the app’s Bolus Advisor feature, which advises users on how much insulin to administer based on data from the Accu-Check blood glucose meter, could prompt users to inject the wrong amount of insulin. The bug is apparently activated when the OS feature within the app detects a change in the smartphone setting.

The recall affects versions 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1 and 2.1.0 of the software.

Company officials learned of the bug in certain Android and iOS versions of the app last June and asked users to update to version 2.11 and clear all data from their Accu-Check sensor before initiating the new app. They also urged users to monitor insulin intake and effects for several hours.

Meanwhile, the FDA recently gave its approval to Glooko’s Mobile Insulin Dosing System, which pairs with an mHealth app and allows doctors to set a dosage and pull data from the patient's glucose monitor to recalculate levels based on the reading.

"There's an enormous unmet need for both [clinicians and patients] — clinicians who aren't comfortable with dosing and therefore don't put people on long-acting insulin," Glooko CEO Rick Altinger told CNBC. "It's a wonderful drug if taken in the right amount at the right time in the right way. This overcomes a big need for clinicians and saves them time. For patients, math is hard."

This isn’t the first time Roche has had to issue a recall for the app for this problem.

The company received FDA clearance in April 2015 – the first mobile platform offering insulin dosing recommendations to receive federal approval - and was forced to issue a brief recall one month later when the app, available then in only the Android version, issued the same incorrect information to users in South Africa, Germany and Italy.

While mHealth tools and technology have long proven invaluable in helping people with diabetes and their doctors with daily care management and coordination, healthcare providers and regulators are under constant pressure to ensure the connected devices are capturing accurate data, and that the data is used in the right way to support clinical decisions.

In 2105, the Global eHealth Unit of the Imperial College London released a study that indicated a majority of the insulin dose calculator apps available were unreliable and put patients at risk.

According to the study of some 48 apps available in app stores:

  • Only 30 percent documented their calculation formula;
  • 91 percent lacked validation techniques for numeric inputs;
  • 67 percent carried a risk of inappropriate dose recommendations due to their calculations not matching the stated formula, failure to update appropriately to input changes, or violating basic clinical assumptions; and
  • 24 percent crashed or froze unexpectedly.

“At this point, the most important take away here is that physicians and other healthcare professionals need to know these apps are out there, they are untested, and may even be unsafe,” Satish Misra, MD, a Cardiology Fellow at Johns Hopkins Hospital and founding partner and managing editor of iMedicalApps, wrote on that website in May 2015. “Given the increasing number of patients using their mobile devices and apps to manage their health, it’s important that we be proactive and advise patients that they shouldn’t waste their time and money on these apps. It’s just a matter of time before well tested, well designed standalone apps appear in the market for this purpose. Until then, being proactive can help keep patients safe.”

Along with insulin dosing apps, blood glucose meters have also come under scrutiny for their ability to accurately and reliably capture patient data.

Last August, the Diabetes Technology Society issued a report indicating two-thirds of the 18 most popular blood glucose sensors don’t meet established standards for accuracy. The meters represented 90 percent of the commercially available digital health devices used by those with diabetes between 2013 and 2015, the study reported, and were tested were developed by Bayer, Roche, Arkray, Agametrix, Abbott, LifeScan, Prodigy, Omnis Health, HDI/Nipro, BioSense Medical, Diabetic Supply of Suncoast and Philsys.

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