Emerging Technologies: Let’s Not Jump the Gun

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We read with great interest the article by Alexander and Joshi1 on “Smartphone Application-Based Medical Devices: Twenty-First Century Data Democratization or Anarchy?” GlucoWise™ is mentioned prominently in the article as a noninvasive glucose measurement device. The article discusses this technology, which combined with an iPhone application, measures, organizes, and uploads blood glucose measurements. It is cited as one type of promising functional mobile device applications that might assist with shared medical decision making, and potentially benefiting patients and saving healthcare costs. We agree that “…the onus of validation falls on us in the healthcare community.”1 However, we caution against prematurely touting an unproven technology.
Needleless blood glucose monitoring is the dream for many patients suffering from diabetes. Despite years of work and millions of dollars invested every year, the reality is, decades later, not one single noninvasive glucose measurement product has become a viable product in the U.S. market. The GlucoWise™ device “extracts” glucose levels “by a noninvasive technique that transmits low-power radio waves through a section of the human body, such as the area between the thumb and forefinger or the earlobe.”2 Their website2 indicates that the frequency range used is about 65 GHz, but there is no information about the expected mechanism of interaction with glucose at that frequency, except the statement that: “These waves are large enough to allow penetration through the tissue, yet simultaneously small enough to provide sufficient resolution of the blood regions inside the tissue.”2 Like every noninvasive method based on radiofrequency or microwave impedance, there is no frequency band that is specific for glucose in tissue, and no matter how many frequencies are interrogated, the result is a “bulk” response from the impedance of tissue. The impedance may change with glucose concentration, but no data have yet been presented using this technology that accurately predict glucose values.
Also according to their website, “This device is currently in development and clinical trials, and will be available to purchase once clinical trials are completed.” In addition, it states “we expect to start taking preorders in late 2018.”2 Alexander and Joshi1 reiterate by writing: “It is currently in clinical trials.” But no trial was found at the ClinicalTrials.gov website. The website also states that “GlucoWise™ will exceed industry standards for self-monitoring blood glucose accuracy.” Without any clinical validation data, these statements are simply premature and misleading to millions of patients with diabetes. As Dr John L. Smith wrote in his book The Pursuit of Noninvasive Glucose: “Hunting the Deceitful Turkey,” “One of the most disturbing aspects of this field has been perennial announcements by fledgling companies that the problem has been solved, and that people with diabetes will no longer have to stick their fingers. These have been premature and, almost without exception were meant to generate ‘hype’ in order to increase awareness of a company that is trying to raise money, and equally frequently, they raise false hopes in people who need the product. News media have never been able to resist reporting these ‘end-of-finger stick-testing’ stories and they have a fresh audience each year, as hundreds of thousands of people are newly diagnosed with diabetes.”3
The overzealous advertisement of premature healthcare products place patients with diabetes in extremely vulnerable positions, especially when their medical knowledge is limited. As leaders in healthcare, we must make sure that we do our due diligence before publishing information about new technologies.
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