In Response

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Excerpt

We thank Liang et al1 for their interest in our article.2 It appears that they have particular expertise and passion regarding the topic of noninvasive glucose monitoring. Our mention of the proposed Glucowise (MediWiSe, http://www.mediwise.co.uk/) device was intended only as one example, among many others, of one category of smartphone application (app)-based medical devices, namely those that are coupled to external hardware. The mention of this device was merely to help the reader understand that such devices are being marketed to patients. However, this particular category of device (coupling smartphone apps to external hardware) is required to submit to regulation from the Food and Drug Administration (FDA), so the concerns laid out by Liang et al1 would be adequately addressed through clinical trials before patients would be able to purchase such a device. To be clear, our mention of any device does not indicate that we are advertising on behalf of, or espouse, the efficacy of any such devices.
One of the main points of our article was to highlight the differences in the regulatory burden on devices that couple a smartphone app to external hardware when compared with the apparent lack of such a burden on devices using only the onboard internal hardware of a smartphone.2 Our conclusion was that the latter category of smartphone app–based medical devices is most in need of validation studies from the medical community because this category is readily available to our patients, yet it escapes the regulation to which all other medical devices must submit. To that end, we previously published a validation study showing that 4 popular iPhone app-based vital sign monitors available to consumers had poor correlation to actual vital sign monitors.3
In summary, although noninvasive glucose monitoring devices would have significant benefits for patients, it appears that there are substantial technological problems that would need to be solved before they reach similar efficacy to invasive monitors. Fortunately, the FDA is an ally with them in protecting patients from inaccurate or dangerous devices. It will require the expertise and passion of many other providers to protect our patients from the unfounded and unvalidated claims of other manufacturers. This is especially so when manufacturers target the gaps in FDA medical device regulation, such as with smartphone app-based medical devices that do not utilize external hardware.
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