Tuesday, 4 April 2017

Socks With Sensors To Prevent Neuropathic Foot Damage (Vid)

Today's long post from healthline.com (see link below) is nevertheless an easy and interesting read that will appeal to many readers with neuropathy in their feet. It's important to state right from the start that these socks (subject of the article) will do nothing to prevent or improve your neuropathy but will alert you to any physical danger (e.g. ulcers) that you may not notice due to lack of feeling and as such can be seen as a valuable tool in harm prevention. As is clearly stated: "We don't prevent neuropathy, we prevent the complications that come with neuropathy. We prevent ulcers and amputations." That said, the article does read a little like an extended advertisement for a product and this blog tries to avoid anything with potential for commercial gain. However, the story behind the development of these socks does suggest a genuine interest in improving the lot of neuropathy sufferers and more than that...it makes sense. It's also clear evidence of the potential for modern technology to improve people's health. It's long but absolutely not tedious and is well-worth a read.

Siren Socks: Revolutionizing Diabetes Foot Care with the Internet of Things
Written by Amy Tenderich | Published on February 27, 2017

Got neuropathy in your feet?

We hope not, but if you do -- or suspect that you might -- you will absolutely want to know about a new company called Siren Care. It was founded by young Chinese-American entrepreneur Ran Ma, who after completing a Biomedical Engineering degree at Johns Hopkins University, freaked out her parents by spending hours holed up in her bedroom sewing socks.

She had a brilliant idea to embed tiny sensors that would connect to an app to track temperature and localized ulceration risk. It panned out big-time!

The socks she invented recently won the coveted TechCrunch "hottest new hardware" award at CES, and the 2016 Health 2.0 "best newcomer in digital health" competition. And medical experts are now saying "what they have done with embedded IoT (Internet of Things) sensors and smart materials will totally redefine how patients can self-manage complications as a routine part of their daily life." Wow!

Please join us for this chat wth Ran to learn about Siren Socks, and possibly win a set of your own!

Q and A with Ran Ma, on Siren Socks for Diabetic Foot Care

DM) Ran, pioneering ‘smart socks’ for diabetic neuropathy is a pretty unique path... Can you share a bit about how you got here?

RM) I was born in China but I grew up in Texas and then I lived in Baltimore, Chicago, Denmark, Sweden, Germany and now back to the States in San Francisco.

My background is biomedical engineering. I studied at Johns Hopkins, and then afterwards, I actually worked in the Department of Plastic Surgery at Northwestern, under Dr. Maldonado. While I was there, I worked on a project called Biomask. We actually developed a wearable mask that would regenerate your face, using stem cells, and this was targeted for burn victims and war veterans. This was right after the Iraq war and because of the research we did, I learned a lot about wound healing, wound formation, also wound prevention. My lab also worked on diabetic foot ulcers. That's just something that really stuck in my mind.

I also come from three generations of doctors -- so my grandparents, my aunts, uncles, and my parents are doctors. My father's actually a surgeon. He cuts people every day and for me, I want to dedicate my life further up in the chain of medicine, towards the side of prevention. I really want to make great tools that are easy to use, and give people the right data at the right time, so they can take control of their own health. I always say if I do my job right, I could put my parents out of a job.

Do you have a personal connection to diabetes?

No I don’t, but my co-founder Jie Fu has lots of diabetes in his family, and some of his relatives have unfortunately suffered some of the more severe consequences.

As noted, both my parents are physicians in China – my mom does hematology so mostly leukemia, and my father works on cervical and ovarian cancers, so very late-stage cancers and they lose a lot of their patients unfortunately because it is so late-stage. That's why I want to focus on prevention.

For me, it's about knowing that diabetic foot damage is a very serious problem with very severe consequences, but it's preventable and there's strong clinical research showing that temperature monitoring can make a big difference in prevention.

So you came up with this ‘crazy idea’ to embed sensors in socks?

Here I was a biomedical engineer who was going to go to medical school, and I told my parents, ‘You know what? I'm sewing socks in my room by myself.’ My parents thought I had lost my mind. I was buying components off the Internet and just sewing it together… because it's one thing to have an idea in your head, but another to put it into physical form.

So I had this sock that was all misshapen, connected to a circuit board with all these wires coming off it (and) I went to the big annual Diabetic Foot Conference DF Con two years ago and basically said, ‘Hey, podiatrists, I'm gonna make a sock, it's going to detect injuries in real-time and then it's going to connect to a phone and your patients are going to be able to wear this and it will be soft and washable.’ And they looked at me like I was crazy, basically... because the early prototype really was just crazy-looking, but we’ve come a long way.

Fill us in on your current team, headquarters and manufacturing facilities?

The company was founded in February 2015 by myself and two co-founders: Jie Fu, whose background is electrical engineering and hardware mass production, and Henk Jan, whose background is global textiles sourcing -- he worked in the textile industry and he set up one of the world's largest manufacturing groups for textiles.

So our leadership is made up of biomedical engineering (my background), electrical engineering, and textile manufacturing. We have a team of 5 and are currently expanding.

Our headquarters are in downtown San Francisco, and we’re currently doing some manufacturing in China, with final assembly in the U.S. We plan to move more of the production to the U.S., but that's still in the works right now.

Hasn’t it been common knowledge for a long time that temperature monitoring can help with foot health? If so, what’s really so revolutionary about using this technology in socks?

You're absolutely right. Temperature monitoring has been around for at least a decade or more and it's been published in Diabetes Care and other leading journals by Dr. Lavery and Dr. Armstrong. But there's been a lack of technology.

A few years ago the technology didn't exist to make a wearable device for temperature monitoring, right?
 In recent years sensors are getting smaller and cheaper and people are putting them in bands, like Jawbone, etc. and all of this has happened because of the emergence of IoT (Internet of Things) tech. Now sensors have gotten small enough that we can actually incorporate them into fabric.

The other thing that has happened is a revolution in design thinking. As you well know at DiabetesMine, even just a few years ago the focus was, ‘This works in clinic, great!’ but (no one was) thinking about it from the patient’s side – as in:

‘If I were living with diabetes, could I use this tool?’ Even though it works in clinics, even though my doctor can use it, does it actually make sense for me to take these bulky tools home? 

There are other solutions on the market: temperature monitoring wands like the TempTouch foot thermometer, a temperature monitoring carpet and a bathroom scale, and I think those are really great and very pioneering in the field. Our team's goal is at-home prevention, empowering the user by creating something that’s easy to use and monitors continuously, so you can have a sense of security at home. So that's why we're focused on a wearable solution.

OK, so how exactly do new ‘smart’ Siren Socks work?

They monitor six spots on your foot, based on the six most common sites of injury according to clinical trials, and we actually monitor your two feet and compare the temperature difference between the same spot on each foot.

When you have a difference of more than 4 degrees Fahrenheit or 2.2 degrees Celsius, then we know that inflammation is occurring, and that means your body is fighting off injury; that's when we give you an alert on your phone. The point is, something has happened and your body is fighting that injury, reacting with inflammation and that's followed by a rise in temperature. We pick up on that and we alert you. 

And you offer the first continuous temperature monitor for feet, right?

Yes, it's very important for us to be a continuous monitor: All the other solutions mentioned are point solutions, meaning you take one measurement a day. You don’t know what happened before or afterwards -- what about the other 23 hours and 50-something minutes in the day? Since there's no reference, it’s even harder to determine why changes might occur.

Because we take so many measurements over time, we're able to filter out false positives. If it's a random spike (in foot temp), we know that's not normal. Inflammation is a sustained temperature difference averaged over time, it's a very particular signature and that's what we can pick up with our socks.

Another benefit is personalization. Maybe for you, one of your feet is just warmer because you have circulation problems or it’s just genetic. Our technology creates a baseline per user over time, so it's a lot more powerful smart tool that can learn from you over time.

Wait, if you’re targeting people already living with neuropathy or other foot conditions, how are these socks ‘preventative’?

We don't prevent neuropathy, we prevent the complications that come with neuropathy. We prevent ulcers and amputations.

What happens to people with neuropathy is they have a foot injury and don't realize it for a week, two weeks, two months even I've seen. And then you go see your doctor and the first thing they do is wheel you into the surgery room!

With our socks, if you have an injury, you might not feel it but you’ll see it with temperature and we alert you. Then you go see your doctor and he/she makes a diagnosis with the X-ray or with a physical exam and then treats you for it. Just from temperature we cannot possibly know if it's just a callous, or a blister, or Charcot foot – so you need to see your physician. But the early detection helps you avoid ulcers or even needing an amputation.

Don’t the embedded sensors, and that little anklet disc on the side, make the socks lumpy?

No, we take very tiny proprietary temperature sensors, like a grain of sand, and incorporate them into the fabric of the sock, and they send data to our companion app via Bluetooth. The anklet holds the battery and BLE chip. We've designed it to have the thinnest profile and smallest surface area possible, and we are always working to further miniaturize this component.

Back when I was hand-sewing them two years ago, you could definitely feel everything, but now… they are really good diabetic socks. The key point to making smart clothing is you have to make really good clothing first. If I gave you the socks right now, you would never know they were smart socks because you couldn't find the sensors.

Can you wash them like normal socks?

Yes, our socks are machine washable and dry-able, you don't have to charge them, and they're completely soft and flexible. They're super-absorbent and have no seams on the outside or inside, and we all know that's important because diabetic socks should be seamless so you don't have any pressure points on your feet. Right?

So we're really creating a great diabetic sock to start with and then we give it intelligence, to protect your feet.

How does the Siren app work?

The basic functions are of course that you can see the current status of your feet and it's very easy to understand, color-coded green, yellow, and red. And of course we walk you through the recommendations when an injury or potential injury is detected. The app may suggest checking your feet, reducing activity or reaching out to your healthcare professional.

You can see your foot temperature over time, and your foot health over time and that helps you know, when did this inflammation begin? This is why continuous use is important. You can see for example if inflammation was caused because every day you're wearing a certain pair of shoes that are just too small. One of the main causes of diabetic foot ulcers are shoes that are too small -- because if you can't feel pain, you don't realize you're buying shoes that are too small. So our app actually helps people start looking at their habits.

Can you share the data directly with your doctor?

Right now the Siren app basically sends you alerts on your smartphone if there are significant changes in your foot temperature – it’s alerting you to go see your doctor. The data is in the cloud and you access your account on our website or though the app, where you can easily print it or send it to your doctor in file format, but we don’t have direct data-sharing yet. That’s something for the future.

Also, at the end of the year we're going to be rolling out a solution for people living with diabetes that don't have access to a smartphone, like what we're offering but online (instead of app-based) so you can also use our smart socks without a phone.

Eventually we’d like to have a Call Center that can alert users who can’t get those alerts and alarms on a phone.

Can you add notes into the app, like about what shoes you wore or what activity you did that day?

Yes, people can add notes like, ‘Wore my new whatever-shoes,’ and then you may notice the next day after wearing this pair, you're always getting inflamed, so you can think maybe it's those shoes. It really often is the shoes you wear, and that's something you can pick up on.

In the app you can also check the battery life of your socks, track how often you wore them, which ones you're wearing, and how often you washed them. I think one of the key items is, we can tell you this week you only wore your socks 40% of the time, so maybe next week you can aim to wear them 60% of the time. The more often you the wear socks the more protected your feet are. And if you have neuropathy, you have to wear good socks anyway. That's the number one recommendation, right? We help you quantify that.

So this has big potential to help anyone with diabetes, type 2 or type 1?

Neuropathy can happen to anyone. It does happen to people with type 1 and type 2. It's usually a little bit older population, but I've also seen it in people in their 20's and 30's. It just happens, your nerves start dying, getting eaten away and it usually happens in your feet and hands first, because those are your longest nerves. Hands are not as dangerous because you see your hands every day, but you don't check your feet every day or look at them as closely, so damage can go unnoticed. That's why it's very important to take care of your feet.

Have you completed clinical studies on Siren Socks, showing effectiveness?

We did an initial small test and are now scaling. We’re actually recruiting patients right now with Dr. Reyzelman, a podiatric surgeon at UC San Francisco. This will be a published result, ongoing into March including 30 patients.

I'm also giving a talk at this year’s DF Con Diabetic Foot Conference, at the end of March. That’s the biggest diabetic foot conference in the U.S. and I’ll be presenting the background of temperature monitoring, the current form factors, and why it was important to bring up a smart sock to fill the technology gap right now. And hopefully we'll have some initial results that I will present at that conference. It's a huge deal for me to be a speaker there, because as noted, I went to this conference a few years ago with a VERY rudimentary prototype and I think I scared some of the physicians there. So now two years later, we've progressed so much.

What’s the situation with regard to FDA approval?

We are very firm in saying that we are a tool and not a diagnostic, and that doesn't currently fall under FDA scrutiny.

The studies we’re doing are more to test compliance and user experience. We have entry interviews and exit interviews. So we ask, ‘Do you enjoy the solution? Is it easy to use? Do you like the colors?’ Very basic questions like that are important because we already know that temperature monitoring works, there's no doubt about that. But we need to know: can people use this solution? It’s important to do field studies where you even go into people’s homes to see how they use it, how does it work for them?

Tell us about the prestigious TechCrunch award you received for Siren Socks...?

We just won the TechCrunch Hardware Battlefield competition at CES in January, and that was a huge deal, as they screen I think somewhere around 1,000 of the newest, hottest hardware companies and they narrowed it down to 12.

Twelve went on stage and did a live demo and then they narrowed it down to four, who did a final demo, and they picked one, and we were actually that one! It was a huge honor, we didn't think we would get that far because most of the other companies were one or two or three years older than us.

But I think one of the reasons that we made it so far is that we actually brought a patient on stage, Judy, who has been living with diabetes for seven years. She is 73 and has retinopathy and neuropathy – we had to help her on stage because the lights were so bright. She actually wore our socks on stage and we live-streamed her foot data, so it really made the story make sense, you know when you see these socks in action. You could see how much Judy enjoyed wearing them, she was modeling them in front of the judges and we think that’s great because it helps raise awareness that diabetes touches the lives of so many people.

And you won an influential Health 2.0 competition as well?

Yes, in Fall we also won Health 2.0 Launch, which is strictly digital health, encompassing software and hardware. You know, they’ve had some really great companies that have won over the years, like Basis that was purchased by Intel, Glimpse that was a runner-up and they were recently acquired by Apple, and Castlight Health also went through there. They definitely pick winners.

That one is more bragging rights than an investment prize, but TechCrunch… really brought a lot of momentum to our fundraising. We are raising our seed round right now and I must say it's going very well, especially after CES.

Wait, so you did all this pre-seed funding?

Yes exactly. We had a very small pre-seed round of about $500K last year, but most of the other companies that went on stage with us had raised $4-$5 million seed round and they were raising their A Round financing already, so they are one to two years ahead of us. We move fast.

And you got a lot of great exposure… even at home?

Funny story about my mom, who as you know is a doctor in China. I was supposed to go there to visit for Chinese New Year and she was really disappointed that I had to cancel the trip because we had all of this going and we're fundraising.

But two or three weeks ago she turned on the TV to this channel called ‘Chinese People Around the World’ she watches every day during lunch and she actually saw me there, on Chinese National TV! She was making noodles and she almost burned them all because she was running all around the room trying to find her phone so she could record it, then she was texting me all frantically, ‘Oh my God, did you know you were on TV? Can you find it online can and send me the video?’ They even translated all of our presentation to Chinese, and I had no idea.

They look for entrepreneurial Chinese people who've done cool things around the world and they report about it, so I guess they found me somehow. I have no idea where they got my Chinese name from, but it was really cool.

Kudos to proud mamas around the world! So please tell us how you are reaching out to the PWD community in particular. Have you connected with any patient advocacy orgs?

We've been doing a lot of work within the podiatrist community and diabetes HCP groups to get the word out. I am also doing a few podcasts with diabetes experts, and we're coming out with a bunch of blogs (that offer) educational background on temperature monitoring, how important it is and the history of it.

We were also included in an article published in the November ADA Diabetes Forecast magazine on what makes a great diabetic sock.

As far as reaching the patient community directly, that's very important -- getting people involved and getting their feedback. So talking to you at the ‘Mine is one of our avenues…

Glad to help if we can! We see you have an introductory pre-order pricing set up. Tell us about the offer and when the socks are expected to ship?

Our socks are priced at $180 for seven pairs of socks, but right now we’re doing a pre-sale, at a $60 discount. So it’s $120 for a pack of seven, that should last you six months. There's also an option online to purchase smaller packs, of one, three, and five pairs.

Right now it’s all online ordering directly from us, and we expect the socks to ship in Summer. We’re also in talks with distributors to bring the socks into retail stores like Wal-Mart, CVS and Walgreens. But that won’t be rolling out until later this year.

You talked about design, but these socks currently only come in plain black and white versions, correct?

We're going to make our socks as attractive as possible. We have thought about different color variations, (and) we've already come up with Christmas designs, Halloween socks, summer, fashion versions, etc. for the future.

Of course, you shouldn't be wearing high-heeled or other fancy shoes if you have diabetic neuropathy. You should wear comfortable shoes that are well padded and fit your feet properly and we help you with that.

And the life expectancy of a pair of Siren Socks is six months?

Exactly, we replace all your socks every six months because that's standard in diabetic foot care -- every three to six months you need to replace all your socks to minimize spreading infection and also if there's a thin area in the sock material, that's where a foreign object can penetrate and get to your feet. The only line of defense is your socks, so you want to make sure they’re very thick and cushioned and the fabric is in the best shape possible.

And just a reminder: you don’t have to charge these socks, even though they’re outfitted with smart technology.

Finally, what’s a Twitter-style message you might want to send to the Diabetes Patient Community from your vantage point tackling foot damage?

I would say take care of your feet, and the future is here: we’ve dreamt of a world where we can have access to the right data at the right time and that future has arrived!

I don't know if that's a good Twitter message, but I’d want your readers to know there are lots of people – lots of other teams like us – working very hard to make tools easier to use and to bring science into your home in a way that addresses a problem and helps.

Thanks so much Ran -- That’s inspiring to say the least. We thank you for your ingenuity, down to our diabetic toes!


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