{"id":2295,"date":"2017-08-10T13:32:21","date_gmt":"2017-08-10T04:32:21","guid":{"rendered":"http:\/\/promea2014.com\/blog\/?p=2295"},"modified":"2017-08-10T13:32:21","modified_gmt":"2017-08-10T04:32:21","slug":"post-2295","status":"publish","type":"post","link":"https:\/\/promea2014.com\/blog\/?p=2295","title":{"rendered":"\u3082\u3046\u3059\u3050\u6301\u7d9a\u30b0\u30eb\u30b3\u30fc\u30b9\u6e2c\u5b9a\u304c\u5bb9\u6613\u306b\u3067\u304d\u308b\u304b\u3082\u3057\u308c\u306a\u3044"},"content":{"rendered":"

\u79c1\u306f\u3001\u7814\u7a76\u306e\u305f\u3081\u306b\u30d5\u30ea\u30fc\u30b9\u30bf\u30a4\u30eb\u30ea\u30d6\u30ec\u3068\u3044\u3046\u6301\u7d9a\u30b0\u30eb\u30b3\u30fc\u30b9\u6e2c\u5b9a\u5668\u3092\u3068\u304d\u3069\u304d\u8eab\u306b\u3064\u3051\u3066\u3044\u307e\u3059\u3002\u30a2\u30e1\u30ea\u30ab\u306e\u30b7\u30ea\u30b3\u30f3\u30d0\u30ec\u30fc\u306e\u30d8\u30eb\u30b9\u30b1\u30a2\u30d9\u30f3\u30c1\u30e3\u30fc\u3067\u3042\u308bSano Intelligence\u306f\u4e00\u822c\u306e\u4eba\u306b\u3082\u5229\u7528\u3067\u304d\u308b\u3088\u3046\u306a\u6a5f\u5668\u306e\u958b\u767a\u3092\u76ee\u6307\u3057\u3066\u3044\u308b\u3088\u3046\u3067\u3059\u3002<\/p>\n

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Nobody Needs This Silicon Valley-Made Blood Sugar Tracker for ‘Wellness’ and Lifestyle<\/span><\/h2>\n<\/header>\n
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Sano\u2019s glucose tracker. Image Courtesy Hyper Wellbeing.<\/span><\/figcaption><\/figure>\n

Since launching in 2011, Silicon Valley healthcare startup Sano Intelligence has kept a low profile. Despite raising\u00a0$20 million\u00a0in venture capital, the company founded by ex-Bain Capital analyst and bioengineering grad Ashwin Pushpala has yet to release its product\u2014a continuous glucose tracker that sticks to a users\u2019 skin and monitors blood through an app. Gizmodo has obtained new details about the device, and how the company intends to market it as a product for \u201cmetabolic insight\u201d for non-diabetics, rather than to diabetics who regularly need to track their glucose. The strategy means Sano doesn\u2019t need FDA approval, but doctors and diabetes experts interviewed by Gizmodo question whether the product would have any benefits to non-diabetics at all.<\/span><\/p>\n

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Pushpala spoke about the glucose tracker, which the company aims make available through beta release this year, at the tiny healthcare focused Hyper Wellbeing conference in Silicon Valley in late 2016. In a video of Pushpala\u2019s \u201cWellness as a Service\u201d talk obtained by Gizmodo, he reveals the first renderings of the device, which looks like a nicotine patch with a circular piece of metal in the center, containing the bluetooth receiver and battery. It \u201ckind of looks and feels like sandpaper or velcro when you put it on the skin,\u201d Pushpala said in the presentation. \u201cThese are minimally invasive microstructures that are placed on the body.\u201d<\/span><\/p>\n

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A slide from the Sano presentation explaining the device. Image Courtesy Hyper Wellbeing.<\/span><\/figcaption><\/figure>\n

Those microstructures on the bottom of the patch sense interstitial fluid to calculate blood sugar. Then, as Pushpala explains it, the patch \u201csenses metabolic data\u201d (glucose concentration) and transmits it to the app; the \u201craw\u201d data is then sent to the cloud and analyzed. Then, the app would provide \u201cpersonalized metabolic insights in real-time\u201d and would help users \u201cstabilize sugar concentrations.\u201d Tracking glucose levels throughout the day would allow users to see how different things they eat affect their blood sugar levels and metabolism, Pushpala claimed.<\/span><\/p>\n

Continuous glucose monitors (CGMs) have already existed\u00a0for 15 years\u00a0and are used widely by diabetics\u2014people whose bodies either don\u2019t produce insulin or don\u2019t use insulin properly, which can lead to abnormally high and low blood glucose concentrations, necessitating regular monitoring. There are products\u00a0on the market\u00a0made by Abbott, DexCom and Medtronic. They require daily calibration to make sure they are accurate, generally involving a finger prick test with a standard glucose monitor. Pushpala maintains the Sano device doesn\u2019t need external calibration. As medical devices, the CGMs also\u00a0require FDA-approval, while over-the-counter tracking products, such as a FitBit, do not. While Sano hasn\u2019t begun to seek FDA approval, it plans to in the future, but before it does, it plans to launch as an over-the-counter product for people without diabetes.<\/span><\/p>\n

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A slide from the Sano presentation. Image Courtesy Hyper Wellbeing.<\/span><\/figcaption><\/figure>\n

As Pushpala noted in his presentation,\u00a0<\/strong>CGMs are currently sold to\u00a0<\/strong>people with\u00a0type 1\u00a0diabetes (which accounts for roughly 5 percent of cases and develops in children and young adults) and\u00a0type 2\u00a0diabetes (which can develop at any time, and is influenced by diet and lifestyle). In the talk, Pushpala said that Sano wants to expand the current glucose testing market to new \u201cmasses\u201d and \u201ctreat these folks like consumers\u201d\u2014\u201cpreventative\u201d groups of people who are not diabetic, with a focus on those who are \u201coverweight\u201d and \u201cpre-diabetic.\u201d According to Chantelle Darby from Sano\u2019s public relations, the company will also target \u201ca variety of folks\u201d and \u201cthe weight loss management, the fitness crowd will be our focus.\u201d Sano\u2019s\u00a0freshly updated website\u00a0makes it seem like a wellness aid for diet and fitness.<\/span><\/p>\n

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A slide from the Sano presentation. Image Courtesy Hyper Wellbeing.<\/span><\/figcaption><\/figure>\n

\u201cI think they\u2019re just trying to get around the law,\u201d David Levitsky, a professor of nutrition at Cornell University, told Gizmodo. \u201cI think to get FDA approval, they have to demonstrate efficacy. And I don\u2019t think they can, because they don\u2019t know what [Sano\u2019s product] is good for yet.\u201d<\/span><\/p>\n

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\u201c[Sano\u2019s product may be] a little bit more sophisticated than quackery\u2014I\u2019m sure there\u2019s some fantastic technology that underlies it\u2014but even if you had a exquisite measure of glucose, it wouldn\u2019t tell you that much,\u201d Levitsky said. He said that to accurately monitor metabolism, how well your body burns energy to keep up basic functions, you need to know more information than just your glucose levels, including fat burned.<\/span><\/p>\n

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Screenshot of Sano\u2019s\u00a0very recently updated website.<\/span><\/figcaption><\/figure>\n

In a phone conversation with Gizmodo, Pushpala clarified that blood glucose concentration is not the only number that is needed to calculate metabolism, and though his earlier presentation promised \u201cpersonalized metabolic insights\u201d he backed away from this claim in our interview. When we reached out to Sano for clarification, the company specified that the device is only tracking \u201cone very important element of metabolism (glucose).\u201d<\/span><\/p>\n

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Mark Schutta, MD, director of the Penn Rodebaugh Diabetes Center, said \u201cthere isn\u2019t really any merit to\u201d continuous glucose monitoring in non-diabetics, whose blood glucose concentrations will vary throughout the day but are ultimately regulated by insulin produced by a healthy, functioning pancreas. He argues that a healthy person using the device could find out some useful information, for example, that certain foods affect their blood sugar more than they expect, but ultimately, \u201cI think it\u2019s not a useful device. The truth of the matter is that if you\u2019re going to a good primary care doctor and you\u2019re at risk for diabetes, they should be screening you with the appropriate test, either on an annual or bi-annual basis. So, I don\u2019t see much utility in something like this.\u201d<\/span><\/p>\n

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A slide from the Sano presentation. Image Courtesy Hyper Wellbeing.<\/span><\/figcaption><\/figure>\n

Medical CGMs and maintenance can cost\u00a0upwards of $3,000\u00a0out of pocket per patient per year, and are\u00a0rarely covered\u00a0by insurance\u00a0for Type 2 diabetics. (These are high figures, especially considering that Type 2 diabetes\u00a0disproportionally affects the poor.) In his presentation, Pushpala said Sano\u2019s device would cost \u201ca few hundred dollars\u201d over the course of a year.<\/span><\/p>\n

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\u201cI doubt that people without diabetes would persist wearing the device given the cost and inconvenience,\u201d said Janet McGill, MD, Professor of Medicine and Director of the Fellowship in Endocrinology, Diabetes and Metabolism at Washington University. She said CGMs are a \u201cgodsend\u201d for patients with diabetes, but cumbersome and expensive. Added Schutta: \u201cWe can\u2019t get devices like this paid for by insurance companies, for our type 2 diabetics who need them. So why would we have a product that people use who aren\u2019t even diabetic?\u201d<\/span><\/p>\n

McGill also said the risk goes beyond just not being needed or being something people wouldn\u2019t want: \u201cThere is a risk that too much information would create unnecessary worry, concern and health care issues that are not warranted. I would fully expect that the persons needing it the least would be the most likely to want to wear it.\u201d<\/span><\/p>\n

\u201cI\u2019m all for new technology and science that helps detects things early and helps patients become involved in their care,\u201d Dr. Schutta added. \u201cBut there\u2019s this group of people who are susceptible to you know, sort of quackery\u2026 This is a little out there, if you ask me.\u201d<\/span><\/p>\n