Insulin Dosing App Recalled Due to Bug

I am a big champion for the use of mobile devices to empower patients to take charge of their health. This goes beyond just Googling their symptoms, but instead using approved and verified apps to help guide disease management. Apps could help with everything from mental health to diet and exercise.

One area that has intrigued me is the rapid pace apps are setting for disease management, such as the slew of apps targetting diabetes. One of the hottest areas is help managing insulin in patients, such as devices from Medtronic and Dexcom that use continuous glucose monitoring (CGM) technology to companies like Eli Lilly and Roche making apps that partner with their insulin products to manage titration of insulin doses.

But like all things, that doesn't mean, they don't have their downsides. A study published several years back identified multiple diabetes apps that did not recommend correct doses of insulin, which put a damper on the field.¹ But in the past 2 years, there's been an explosion of FDA cleared apps that I had hoped would overcome the wild west feeling of medical apps and help lead to a better era of digital health. However, this past month the FDA issued a Class 2 device recall for Roche Diabetes Care's Accu-Check Connect diabetes management app due in part to an error in the programming.²

The recall (issued February 15) details that there is a bug in the Bolus Advisor feature of the app. Essentially, the drug dose calculator is off, whereby the unit of measurement may change. The note from the FDA identifies the concern: "This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice." Roche's actions have been to release an update to correct this error, and advise users to clear their old data from their Accu-Check sensor and frequently monitor after using insulin afterward to make sure nothing is amiss. The underlying concern here is that patients may not be getting the right dose of their basal insulin, or worse, too much and develop hypoglycemia that necessitates medical treatment.

Now, Roche arguably has led the way for these types of apps getting to the market recently, as they were the first to get clearance for an app that managed insulin back in 2015. As I had previously written about, Eli Lilly and Sanofi have also received FDA clearances for their proprietary apps, though haven't had as many issues that Roche has had.

At this point, I think it's just the fact that this technology is rather new, but it does point out that oversight is still essential for the digital health field. There are a lot of apps on the market targeted for patient care that has not received clinical data demonstrating efficacy that the FDA is concerned about, and I feel pharmacists should recommend at least the ones that have been cleared to keep by proper medical steps. After all, we don't dispense drugs that aren't cleared by the FDA, so why would we do so with medical technology?

References

• Huckvale K, Adomaviciute S, Prieto JT, Leow MK, Car J. Smartphone apps for calculating insulin dose: a systematic assessment. BMC Med. 2015;13:106
• FDA. Class 2 Device Recall AccuChek Connect Diabetes Management App. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=161061. Created February 15, 2018. Accessed March 5, 2018.