Decoding the FDAs Perspective on Diabetes Devices

Insulin infusion pump and blood glucose meter accuracy discussed

By Jessica Swienckowski, diaTribe

The diaTribe team has been attending more FDA meetings of late, and two in particular struck us as very valuable for patients. This [diaTribe issue of] Learning Curve will give you a window into recent FDA meetings concerning the accuracy of insulin infusion pumps and blood glucose meters. In addition, we discuss how accurate current blood glucose monitors are and give you tips on what you can do to obtain the best test results possible.

In general, both meetings we attended were focused on patient safety. Specifically, one addressed the accuracy of insulin infusion pumps and the other the accuracy of self-monitoring blood glucose (SMBG) devices. Although we felt the insulin infusion pump meeting was less productive than we had hoped, we were surprised to see an initiative very recently launched by the FDA setting a higher bar for the kind of information and risk assessment required of manufacturers producing pumps. At the meeting in March, we got the sense that manufacturers do a pretty good job keeping pumps safe. At the same time, insulin is obviously a treacherous medication (more accidents happen in hospitals with insulin than with any other drug, and that is in a space surrounded by doctors!), so additional safety measures are clear positives. While the FDA did not make specific recommendations at that meeting, an upcoming meeting open to the public in May is slated to discuss how manufacturers, health care providers, academics, the FDA, and patients can work together to further improve the safety of these insulin delivery devices.

While insulin pumps no doubt play a very important role in many of our readers' lives, particularly those with type 1 who are intensively managed (though the number of type 2 pumpers is growing rapidly), there is no device more ubiquitous in the "diabetes medicine cabinet" than the blood glucose meter. The goal of the SMBG device meeting that took place in late March was to discuss whether or not current accuracy standards, based upon the recommendations of the International Organization for Standardization (ISO; a nongovernmental organization composed of members from various national standards organizations), are sufficient.

As we understand it, the FDA began to rethink the accuracy guidelines for meters in September of 2009, and is looking to tighten the accuracy requirements for meters in the US regardless of the international guidelines. We were pleased to see that the FDA meeting was characterized by a distinctly cooperative tone – the FDA, healthcare professionals, industry, and patients are all working together to arrive at the best recommendations for future accuracy requirements. No changes in guidelines have been made at this time, but it seems likely from the meeting that the FDA will recommend incrementally tighter standards in the near future. For the remainder of this Learning Curve, we will discuss what current accuracy requirements mean for your readings, what factors influence accuracy, and how patients can obtain the best test results.

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Last Modified Date: November 08, 2013

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