CES 2018 (Consumer Electronics Show)

January 8-11, 2018; Las Vegas, NV; Full Report – Draft

Executive Highlights

  • In exhibit hall news, we were impressed to see an entire section of UnitedHealthcare’s booth dedicated to the new type 2 diabetes partnership with Dexcom. The focus was on the pilot in 10,000 people with type 2 diabetes, though we were shocked to see not only the G5 on display, but also the G6 – its first ever appearance in any exhibit hall (currently under FDA review; launch expected in 2H18)!
  • Also in the exhibit hall, Diabeloop shared its plans to launch hybrid closed loop in France, Sweden, and the Netherlands this year. It has submitted its algorithm for CE Mark. Interestingly, it is working with Cellnovo and Kaleido patch pumps, and discussions are underway as to which pump will come first.
  • We also learned that Siren’s “Diabetic Socks” won a CES 2018 Best in Innovation Award for Fitness, Sports, and Biotech and were blown away by the usability and human factors (100% machine washable and dryable; no charging required). The socks are capable of detecting changes in temperature indicating sites of inflammation prior to ulcer development. Diabnext, a multi-device diabetes AI platform, expects to come to market in the US this quarter. The Medipense smart pill dispensing system for seniors was also of note for diabetes.
  • There wasn’t a robust diabetes presence during CES sessions, though we did appreciate hearing more about WellDoc’s work with Truven to unpack BlueStar’s potential cost savings. We also heard four digital health companies talk about driving engagement, including diabetes work from Fitscript and Sensoria. Mr. Marc Leibowitz, Global Head of Health Technology at J&J, discussed the company’s plans to prioritize prevention through digital health (though he didn’t talk about diabetes, despite J&J CEO Alex Gorsky’s assertion at JP Morgan regarding the company’s commitment to diabetes “we’ll continue to look for ways to make a difference in diabetes …”)
  • We also enjoyed a live demo of Time Inc.’s virtual reality product for healthcare, Teva’s and Phillips’ views on digital health, Neurovalens’ interesting vestibular nerve stimulating headset for weight loss, and multiple perspectives on clinical trials.

Diabetes Technology Highlights

1. UnitedHealthcare booth highlights Dexcom partnership to pilot CGM in 10,000 type 2s – major payer victory for CGM! G6 sensor shown under glass

In the massive CES exhibit hall, we were elated to see UnitedHealthcare’s booth showcase the new Dexcom partnership to pilot CGM, coaching, and wearables in 10,000 people with type 2 diabetes. This came in addition to a Dexcom press release announced during the conference regarding this partnership. What a big win for CGM to appear in a payer’s booth – at CES no less! Dexcom representatives were actually in the large UnitedHealthcare booth, with an entire section dedicated to presenting Dexcom’s G5 (see pictures below). Incredibly, the booth showed the G6 sensor on display – the first time we’ve ever seen it in an exhibit hall! – but unfortunately were prevented from taking pictures. It’s still under FDA review, and as of Tuesday, and CEO Kevin Sayer’s excellent presentation at JP Morgan, we learned that a no-calibration G6 launch is expected in 2H18. A UnitedHealthcare representative discussed the pilot in 10,000 type 2s (first announced in November), emphasizing that the program currently focuses on seniors, and will involve a Fitbit. It was great to see the clear type 2-focused CGM taglines on the plasma screens – “Helping People with Type 2 Diabetes Live Healthier Lives” and “Dexcom G5: Continuous Glucose Monitoring for People with Type 2 Diabetes.” As detailed in Dexcom’s presentation at JPM (copied below), UnitedHealthcare also has plans to incorporate coaching into the program, and the representative noted that determining the best mode of communication (via an app, in-person, etc.) is one of the purposes of the pilot. The partners are also currently discussing how to determine when patients should receive the G5, as education alone can serve as sufficient support for many type 2s. Indeed, this remains one of the biggest questions for CGM in type 2 diabetes – who should get real time CGM, how often should they get it, and when can professional CGM do the job? Dexcom representatives noted that the majority of CES attendees were unaware of the differences between CGM and BGM – an important reminder that even the most tech savvy crowd on the planet  at CES needs education on diabetes tech. (Dexcom last had a booth in 2016, the same year IBM devoted some of its keynote to the Medtronic partnership.) UnitedHealthcare cited strong leadership from Dexcom CEO Mr. Kevin Sayer as pivotal in the decision to expand CGM access to the type 2 population. See below for pictures of the exciting display – we love the focus on educating attendees about CGM and seeing this much commitment from a payer. We’ll be interested to see what this looks like next year, assuming the pilot is a success and expands. Will it add the gen one Verily sensor?

 

  • UHC Pilot Details from Dexcom’s JPM 2018 presentation: This year, Dexcom aims to confirm the value of CGM through its non-intensive type 2 diabetes programs. The exciting UHC pilot in ~10,000 type 2s with CGM+coaching (ramping up in the next six to nine months) received several minutes of airtime. Mr. Sayer emphasized that 24/7 CGM is not feasible in non-intensively managed type 2 diabetes, so Dexcom is focusing on “programs” that offer coaching, education, and guidance. A point of emphasis was medication costs in type 2 diabetes, something Dexcom CGM + coaching might help payers with. Dexcom may even share in these savings – a pretty compelling business model. The goal of the UHC partnership is to develop analytics, data, and programs on how to effectively treat people with type 2. The slide showed a Dexcom G5 and Fitbit tracker, paired with software that educates and teaches skills – e.g., post-meal walking, diet and nutrition, medication optimization, and sleep. Combined with algorithms and predictive models, HCPs will get data on the “ideal” drug therapy, based on a particular patient. A following slide showed a highly compelling before-after CGM example from one of Dexcom’s type 2 studies: the user went from 28% to 79% in range (3x!), and from an average glucose of 212 mg/dl to 150 mg/dl! A third slide showed a nice mix of decision support that mixes patterns (e.g., “You’ve had a spike the last three days at 1pm”) and medication optimization (e.g., “Medication is best taken before bedtime”). It appeared like some gamification could be used too: “Post-meal walking skill unlocked!” This is very exciting and we cannot wait to see what kind of outcomes it can drive in non-intensively managed type 2 diabetes – on that note, however, we feel a new name is needed for this popularion.

2. Diabeloop expects European launch of automated insulin delivery in 2018; Diabnext’s diabetes management AI platform to launch this quarter (1Q18); Medipense pill dispenser for seniors

The CES exhibit hall shared diabetes tech updates from Diabeloop and Diabnext, along with introducing us to Medipense (a smart pill dispenser for those with chronic conditions). We were also intrigued by Medicus, an app that more intuitively displays laboratory results. Read details below!

  • The Diabeloop booth displayed their automated insulin delivery system in the US, which uses its own algorithm, Dexcom’s G5, and either the Cellnovo or Kaleido (ViCentra) patch pump. The company still aims to launch this year in Europe – France, the Netherlands, and Sweden. This is the first time we’ve heard Kaleido’s patch pump will be used in Diabeloop’s system – the colorful, CE-marked patch pump has been at EASD 2016 and 2017 with large booths, but it has been very delayed from a full EU launch. (As of EASD 2017, Kaleido’s Netherlands launch was expected by the end of 2017/early 2018, with a UK launch expected in 2018.) Diabeloop’s system is currently undergoing a two-arm clinical trial to achieve a CE mark, the first of which utilized the Cellnovo pump and has already concluded with “very positive” results expected “soon.” (Perhaps at ATTD?) The second arm of the study will use the Kaleido pump, and according to the booth representative, will collect data also intended to help gain reimbursement. Diabeloop CEO Erik Huneker told us Diabeloop has already submitted its “part” of the hybrid closed loop system for CE Mark (presumably this means the algorithm); however, there are still discussions underway as to which pump is going to come first. The system will use Dexcom’s G5. For Diabeloop, the biggest commercial risk (in our view) is definitely on the pump side – Cellnovo has not been able to scale and Kaleido has not formally launched in Europe to our knowledge. On the plus side, if things on the pump side are ironed out quickly, Diabeloop will be first or second to market with hybrid closed loop in Europe – the MiniMed 670G is expected to launch outside the US by this April. Diabeloop also expects to initiate a trial for pediatric use of the system this year and has received a European government subsidy to help in the development. The company isn’t in any rush to bring the system to the US, but plans to begin FDA discussions this year.
  • At the Diabnext booth, we learned that company plans to launch its diabetes management artificial intelligence platform this quarter (1Q18). The company is closing a Series A round of $5 million, and is actively seeking out strategic partnerships for the “all-in-one” digital diabetes management platform: a cable to Bluetooth-enable non-connected meters (Gluconext; think Glooko’s MeterSync Cable); an insulin pen clip attachment to capture doses (Clipsulin; slightly dubious in design); an app that uses AI and pictures to calculate carbs on the plate (Snapcarbs); a connected pill bottle top (Vigicap); a coin-sized activity sensor that can be carried in a pocket (Vigifit); and a wireless body composition scale (Vigiscale). This is certainly a lot of hardware to manage, let alone to pull actionable insights from! The representative mentioned Samsung Ventures, BD, Dexcom, and Medtronic as a few “potential” partners. Diabnext also hopes to integrate coaching into its platform and is in discussions with several coaching providers. Finally, the company is interested in incorporating pumps and CGMs, as it currently is limited to BGM readings using its own dongle. Gluconext and Clipsulin are available for preorder on the company website for $39.99 each or $79.98 as a package deal. Diabnext also has an open API program, with Amazon Alexa, Google Home, Apple Watch, HealthKit, and Samsung Health reportedly integrated. The representative also shared that Diabnext is engaged in multiple studies, and that one of the US studies is expected to announce preliminary data this year, possibly at ADA 2018. At AADE, the company said it would launch 10,000 sets – including the smart pen attachment, connected pill bottle top, and BGM cable – across the world in October for a trial that will begin this year and proceed into 2018. (we’re not sure if that has started.) We did not get an update on how talks are going with the Singapore, France, Japan, and Taiwan governments to begin pilots.  
  • Medipense is a smart pill dispenser for seniors with chronic conditions. The large device is loaded with up to two, seven-week blister packs filled for the individual patient by the pharmacist. The packs separate the pills by time of day (morning, noon, evening, bedtime) and each serving can contain multiple pills, so that if a patient is instructed to take two medications in the morning for example, each packet indicated for morning administration will contain both those pills. The booth representative informed us that these blister packs are already in use in Canadian pharmacies and are slowly penetrating the US market. The dispenser reads the barcode on the pack and automatically downloads the patient data, knowing exactly when to dispense each packet. The device can call out reminders to patients to take their medication (either by voice or music) and can deliver instructions on how to take the medication, as well as ask questions like, “did you remember to take your pills this morning?” The dose and time are recorded, allowing providers to track medication interaction and adherence. Additionally, the device screen can display pictures of each drug and can be used for direct video conferencing with the patient. Medipense has obvious implications for people with diabetes on multiple medications (which is to say most people with type 2 diabetes), especially those experiencing cognitive declines. The company is currently manufacturing and hopes to be commercially available this year starting in Canada. They plan on filing with the FDA as a Class I Medical Device. Other “smart hub” adherence approaches include Pillo (touchscreen with smart medication dispensing) and PillDrill (smart vial scanned over a hub to log dose information).
    • Beyond diabetes, Medipense also has potential to help address the opioid epidemic. As the representative pointed out, once the pills are loaded into the device, they’re essentially locked away from the user. In this way, prescribed pain medication could be controlled, preventing patients from abusing drugs. For those already suffering from addiction, substances such as methadone could also be more effectively controlled, helping to ensure the appropriate dose is taken.

  • Medicus is a free patient-facing app that translates complicated medical laboratory results into easy-to-read, actionable information. Different laboratories link up with the program and send the patient results to the app. The app can then read a picture of the results and send advice directly to patients, incorporating other patient data streaming from Fitbit or any Apple device. Examples of advice include substitutions for unhealthy food, sourced educational material relevant to the individual user, and reminders (e.g. “have you drunk two cups of water today?”). The app is currently available in Dubai, Germany, France, and Austria, and the company hopes to launch a German version in the next six months. France is Medicus’s largest market to date, as there are multiple laboratory systems and providers have been especially eager to see these data from these sources integrated. The company is also planning to release a premium version involving in-app purchases, which would supply more detailed recommendations. The approach reminds us a bit of Wellness FX in the US, a direct-to-consumer lab testing service that also provides really nice visual displays of data. (Adam has used it and you can see an example here.) Medicus is currently focused on securing reimbursement from medical laboratories. We could see Medicus being very relevant in diabetes management, combining A1c results with CGM or diabetes medication data. Integrating glucose or insulin data with laboratory results evaluating renal function or heart health could be extremely valuable too.

3. WellDoc’s Dr. Anand Iyer highlights encouraging BlueStar/Truven (IBM Watson Health) cost analysis; commercial vs. Medicare claims data

At the Digital Health Summit, WellDoc’s Dr. Anand Iyer provided an overview of BlueStar, highlighting the just-announced economic analysis conducted in collaboration with Truven Health (IBM Watson). The work demonstrated potential for BlueStar to save $254-$271/user/month, based on the Truven Health modeling analysis and the ~1.7%-2.0% mean A1c declines conferred by the BlueStar type 2 diabetes management app in clinical trials and real-world results (n=3,000) from 2011. In this deeper analysis, Dr. Iyer shared the different annual cost levels associated with distinct A1c bands, which Truven then paired with BlueStar’s A1c reduction data. On average, someone with an A1c <7% costs ~$13,000 per year, while those with an A1c >9% approach average annual costs of ~$17,000-$20,000. Dr. Iyer also shared adjudicated claims data (average) by A1c band for commercial vs. Medicare patients, which showed similar trends (higher A1c’s = higher costs). Annual costs were slightly higher for commercially-covered patients. Dr. Iyer was confident regarding the results, noting that one “can pretty much predictably tell [payers] that this is where you’ll save, on average.” We’re encouraged to see this kind of analysis, as it hopefully speaks to the value of reducing A1c as a short-term win too – if patients with higher A1c’s cost more money annually, there is value in A1c reductions even for a short-term-focused payer or employer. Hopefully this analysis drives more payer interest in BlueStar and proven digital therapeutics. IBM Watson and WellDoc also plan to publish more analyses and a white paper. We do think that more long-term savings would be seen with combinations that include therapeutics (and possibly technology) though this is speculative and we know the instinct is to focus on the short-term though we are not sure that is best from a long-term systems perspective.

  • Truven, now owned by IBM Watson Health, conducted the health economic modeling analysis using the MarketScan Research Database, a group of data sets comprised of de-identified patient-level health data, productivity records, lab results, health risk assessments, hospital discharges, EMRs, and morbidity data from commercial and Medicare consumers. Truven built a “complex custom algorithm” and then applied it to the MarketScan data, quantifying total healthcare costs broken down by A1c levels. This then drove cost savings calculations based on the previous BlueStar research.

  • According to Dr. Iyer, there are two problems the healthcare industry faces in managing any chronic condition: (i) the right data isn’t getting to the right person at the right place and the right time; and (ii) the data lacks valuable insight. To illustrate how BlueStar aims to solve these issues, Dr. Iyer broke down the process into four phases: inform, discover, extrapolate, and adapt (IDEA). Inform is the most basic phase and includes presenting primary analysis of the data (answers the question “What?”); Discover uses known data to draw correlative insights (answers the question “Why?”); Extrapolate uses prediction models to predict and prevent future occurrences (answers the question “When?”); and Adapt leverages learning techniques to provide choices aimed at optimizing outcomes (answers the question “How?”). Dr. Iyer emphasized that BlueStar does not intend to replace the physician by any means. Rather, the digital therapeutic is meant to be a “value-multiplier,” allowing both patients and providers to “stand on technology’s shoulders and reach higher.”

4. Siren’s Diabetes Socks to prevent ulcer formation win Best in Innovation Award for Fitness, Sports, and Biotech

Siren’s Diabetes Socks – achieved a CES 2018 Best in Innovation Award in the category of Fitness, Sports, and Biotech, an impressive visibility win. These injury-detecting socks record changes in temperature, predicting an inflammation site before a foot ulcer develops. Each sock has six embedded sensors and one quarter-sized device that houses the six-month battery (!) and Bluetooth connectivity. The socks are entirely machine washable and dryable (a huge win for usability) and do not require charging. Normal socks for those with diabetes are indicated for six-months, and the representative assured us that the battery is capable of lasting throughout this time period. The socks are based on clinical trials demonstrating a four degree increase in temperature within 24-48 hours to be an accurate indication of inflammation. The sensors are positioned at the most common sites of injury and can alert the user on the free app if problematic inflammation occurs. Cool! The iOS and Android app, which streams data from the socks via Bluetooth, provides live readings, is equipped with sharing capacity, can send alerts to the user, and displays trends over time. There is also a web portal, which physicians can use to track their patients in real time or receive reports. Impressively, the app can deduce when a user’s foot is hot due to exercise rather than inappropriate inflammation – we’d guess this is based on motion, but aren’t sure. The socks will be sold in packs of seven priced “under $200” and will be available on Siren’s website for preorder at $179 starting January 18. Shipping is expected to begin in the Fall. We like the fits-into-my-life seamless design (it really looks like a normal sock) and have high hopes for scalability, as the representative informed us that it is mass producible. Siren is currently engaged in its own clinical study, with more information on the trial expected in February. Intriguingly, the Sirens representative repeated that they can embed “any sensor into any garment.” Apparently, they’ve been asked to create pressure-sensing sheets, moisture-sensing underwear. Even a few years ago at CES, the idea of garment-integrated sensors was very appealing and received a lot of airtime on wearables panels. Thus far, sensors have continued to focus on the wrist, without much focus paid to garment integration. Hopefully Siren can change that!

5. Four CEOs talk engagement in fitness tech and digital health; three with ties to diabetes: Fitscript, Sensoria, Oska Wellness

In a fascinating panel moderated by the highly respected Mr. Eric Taub from the New York Times, we heard from the CEOs of four companies (three of which have ties to diabetes) on how they navigate the compelling intersection between fitness technology and digital health. All four panelists emphasized the need to drive user engagement, but detailed different, sometimes contradicting strategies. Mr. Davide Vigano, CEO of Sensoria, a smart sensor company, highlighted making devices invisible and injecting them into users’ daily routine. However, Mr. Greg Houlgate, CEO of Oska Wellness, which developed a non-invasive pain management device, disagreed, claiming that people are still “married to devices” and need to have a physical reassurance. Mr. Charles O’Connel, CEO of Fitscript, a platform providing exercise recommendations to people with diabetes, focused on creating relevance around data: “the difference between a toy and a tool is relevance.” Lastly, Mr. Jonathan Palley, CEO of Spire, which produces smart respiratory sensors for garments, noted the ever-importance balance of friction and outcome – if a device is unobtrusive and benefits the user, it’s much more likely to be sticky. The truth is probably a combination of all four perspectives, and likely depends on the device and application. Obviously people prefer smaller devices over larger ones, and devices that fit in with life (or are unobtrusive) are likely to be more successful than the opposite. Read below more on Sensoria, Fitscript, and Oska Wellness.

  • Fitscript delivers Glucosezone, an app for people with diabetes, which integrates a slew of data sources and metrics to provide personalized exercise recommendations. The company’s YouTube channel has been viewed by one million global users, with an average engagement of nine minutes/view, and as of August 2016, 200,000 individuals with diabetes have used the program. The company expects its second-generation version of the app to be available January 15. The app is free to download on iTunes and Google Play stores for a free trial, after which users must pay a monthly subscription rate of $12.99. Included are daily live exercise classes, on-demand videos, a guide to lowering A1c and losing weight, and access to certified diabetes professionals (screenshots below). Mr. O’Connel mentioned pumps, heart rate monitors, foot sensors, CGM, BGM, the internet of things, hydration levels, and exercise as some of the available data streams. An algorithm reportedly makes all this data relevant by determining whether a certain type of exercise is safe for the user. A clinical pilot in collaboration with Yale New Haven Hospital was recently conducted to test Glucosezone in type 2 diabetes (baseline A1c >7.5) who were candidates for drug escalation and had a history of poor success with exercise. According to Mr. O’Connel, participants saw an average A1c improvement of two points and achieved weight loss; we were unable to find the study. While Dexcom G5 and certain BGM device readings are streamed continuously to the app, users can also manually input BGM, insulin, food, and medication data. To date, Glucosezone has only been clinically validated in type 2 diabetes, although the company plans to conduct a study in type 1s in collaboration with Yale Nursing School. However, Ms. Laurieann Scher, VP of Partnerships and Integration, shared that Fitscript may initiate a real-world study in the type 1 population either in addition to or instead of a clinical study. Fitscript is also involved in a Diabetes Prevention Program located in New Haven. We haven’t heard much about this app and look forward to understanding it better – we like the pairing for video-based coaching with diabetes data. On the Google Play store, GlucoseZone has 500-1,000 installs and 3.9/5 stars.

  • Mr. Vigano presented Sensoria’s diabetes boot, developed in a collaboration with Optima and announced at the conference. The boot is intended for those with neuropathy and can mechanically offload dangerous excessive pressure. Sensoria’s embedded sensors work to monitor engagement with the boot, utilizing text messaging to alert the user if there’s too much pressure and streaming data to an online dashboard accessible by patients, caregivers, and providers. We were able to get a closer look at the boot in the exhibit hall and though it resembles a snowboard boot in size, the representative said it’s really intended to replace a cast. The boot will be available sometime later this year and the price is yet to be determined. Mr. Vigano acknowledged that the company is not quite where it needs to be in making the product truly sticky with valuable insight, yet was very optimistic regarding Sensoria’s recent partnership with Genesis Healthcare announced at Health 2.0 last fall. According to Mr. Vigano, Genesis owns 450 skilled living and assisted living facilities, touching 55,000 patients each day. As he put it, “injecting human beings into the middle” is critical in ensuring uptake and engagement.

  • Oska Wellness offers a non-invasive pain solution that can be worn anywhere on the body… or not at all. Apparently, the Oska Pulse’s field of activity is so wide (22 inches) that those with Carpel Tunnel Syndrome can keep the device on their desk and still reap the benefits. Upon closer examination, the device looks like larger than NeuroMetrix’s Quell, although perhaps Mr. Houlgate was unaware of the comparison, as he boasted during his presentation that “nobody is offering pain solutions that are non-invasive.” Instead of leveraging nerve stimulation like Quell, however, Oska Pulse promises to reduce inflammation at a cellular level by increasing circulation via a magnetic field. According to Mr. Houlgate, this allows “nutrients to come back into cells quicker.” A booth representative explained that the Oska Pulse aims to imitate the body’s natural healing process and emphasized that there are 60 years of clinical studies to back the science up. The device pairs with an app, which monitors changes in the individual’s pain levels. Oska Pulse is registered with the FDA as a Class I Medical Device, and a randomized controlled clinical trial conducted in collaboration with Scripps is expected for publication in Pain Journal later this month. Mr. Houlgate noted that many diabetes patients use Oska Pulse to “massive benefit.” The device is available for purchase on the company’s website and Amazon, priced at an expensive $399 (to compare, a Quell starter kit costs $249). On Amazon, Quell has an impressive 558 reviews, while Oska Pulse has just six. That said, Oska does have some reviews claiming it really does work.

6. Worrell’s applications of voice user interface technology in diabetes

Mr. Derek Mathers discussed how Worrell, a healthcare innovation firm that designs medical devices, digital health solution, and pharmaceutical products, is leveraging voice user interfaces (VUIs) to improve diabetes care. As noted in our 2017+2018 Reflections piece, we heard more enthusiasm about voice’s potential in diabetes tech, but things are still early. Mr. Mathers pointed to One Drop’s integration with Amazon Alexa as an example of a promising VUI, and we hope to see more emerge over time. Worrell’s digital health team has explored three VUI applications for people with type 1 and 2 diabetes under one two-week feasibility project (n=16). In “Heart-to-Heart” users role-played with Amazon Alexa, which was trained to act as a friend recently diagnosed with diabetes. Mr. Mathers reported that users shared personal stories with Alexa, finding the experience cathartic. However, he noted difficulties in training appropriate voice intonation, which served to remind patients that Alexa isn’t “real.” The “Daily Wellness Survey” involved users setting aside five minutes each day to report on health and feelings, as well as set a personal goal. The study revealed that many felt a responsibility to report to Alexa, which served as a motivator to stick to their goals. Lastly, “My Story” utilized a messaging feature, during which users had 90 seconds (the maximum time available) to discuss any topic they wanted. Time constraints proved to be frustrating. These projects are still early stage but we’re elated to this kind of voice-based journaling and role play happening – given the psychosocial comorbidities of diabetes, perhaps there is potential for these systems to even provide cognitive behavioral therapy or other proven strategies. Mr. Mathers noted that 20 million Amazon Alexa’s and eight million Google Assistants have been sold in the US so far. The trick will be in making the process as simple and delightful as possible. As Mr. Mather’s put it, “VUIs will force user-obsessed, patient-centric design, because otherwise patients just won’t use it.” (We would substitute any technology for ‘VUIs’ in that sentence.)

Digital Health Highlights (with Diabetes Implications)

1. J&J to prioritize wellness and prevention; driving patient engagement through design, data insight, community, and respect

In a packed, standing-room only session, Mr. Marc Leibowitz, Global Head of Health Technology at J&J, Dr. Lewis Levy, Chief Medical Officer at Teladoc, and Mr. Rob Le Bras-Brown, Global Head of Digital Health at Nokia Technologies, sat down with Ms. Jane Sarasohn-Kahn of THINK-Health to discuss how their companies are keeping patients front and center. We were very pleased to hear Mr. Leibowitz emphasize that J&J is thinking a lot about wellness and prevention, despite it being “very disruptive for J&J,” which of course has built a business treating those who are sick. As Mr. Leibowitz put it: “Prevention is inherently cannibalistic to everything we do. There are not a lot of obvious business models for that today, but we think that’s where we have to take human health. If we can figure out how to do that well, the business model will follow.” We couldn’t agree more and are thrilled to hear that J&J is making this invaluable investment in public health – we hope it translates to real commitment in diabetes, given J&J’s Animas exit and an unknown future for LifeScan. Mr. Leibowitz also discussed J&J’s strategy to move away from selling specific products and towards selling a more holistic, unmet need of managing health. For him, it’s all about frictionless, elegant, and surprising experiences, whereas the current US healthcare system provides a “pretty medieval experience.” Mr. Leibowitz cautioned against biases when designing for behavior change, noting the importance of being iterative and nimble in what is tested and learned. Nokia has noticed community is a major driver of user engagement – we’d point to Facebook and Fitbit as obvious examples – as well creating products that evolve with life (e.g., Nokia’s digital scale can switch into pregnancy mode). Dr. Levy described how Teladoc, which currently controls 75% of the telehealth industry, has focused on fostering patient trust and respect through high-quality medical care and compassion. To keep patients coming back, virtual care requires excellence in both the digital and humanistic aspects of the experience. Ms. Sarasohn-Kahn agreed on the importance of respect, citing a Robert Wood Johnson Foundation study showing that those with type 2 diabetes who did not feel respected by their clinician were twice as likely not to be adherent to their medication than those who did feel respected (see the study here). We were especially intrigued to hear J&J’s commitment to this panel and wonder how that will translate into digital approaches for prediabetes and type 2 diabetes.

2. Neurovalens’ vestibular nerve-stimulating headset results in one pound of body fat lost/week

Dr. Jason McKeown, CEO and Co-Founder of Neurovalens, presented a weight loss wearable that seems almost too good to be true – a vestibular nerve stimulating headset called Modius shown to result in a pound of body fat lost per week. Because Modius is a low-risk wearable, Neurovalens was able to bypass the regulatory pathway and go straight to consumer, pricing the headset at $499. They’ve since analyzed 50,000 one-hour sessions of real-world user data (~650 individuals) and found that 80% of users see positive results. Specifically, by week six, most users achieve six pounds of fat loss on average, with the best result recorded at 23 lbs. Dr. McKeown acknowledged that there’s an obvious mixture of accompanying lifestyle changes, and a booth representative at the exhibit hall noted that they do encourage a healthy lifestyle to their customers. Still, Dr. McKeown claimed that some users are achieving these results without any modifications at all. Results indicated a strong correlation between frequency of use and weight loss (see data below), leading the company to recommend using the device seven days/week, up from the initial five days. The wear time is set at one hour per session. Neurovalens is interested in applying Modius to people with diabetes. The booth representative shared that they have reason to suspect Modius could be very applicable, as they’ve anecdotally noticed insulin levels and leptin levels to increase immediately following wear. The company is currently looking into conducting a diabetes study; however, no further details were provided. Given the lack of a control group – and the potential for placebo-driven lifestyle changes from a one-hour wear session multiple times per week – we’re keeping our expectations in check until we see published data.

  • The science behind Modius dates back to NASA studies during the race for space. In hypergravity simulations, scientists noticed that test animals got extremely lean despite an unchanged diet. These experiments weren’t repeated until 2002, when it became clear that stimulation of the vestibular system (a neurological circuit responsible for balance) caused a reduction in body fat. Dr. McKeown detailed a pathway from the vestibular nerve to the hypothalamus, a region of the brain critical in metabolism. By stimulating the vestibular nerve, conveniently located behind the ear, the hypothalamus could be triggered to promote fat loss. The booth representative shared that users are instructed to remain sedentary during wear, as the device can promote a rocking sensation. When asked whether nausea or vertigo-like symptoms were commonly experienced, the representative acknowledged that only one patient in the 20-participant study she conducted reported these side effects, which declined over time.

  • Neurovalens is currently recruiting for a yearlong randomized controlled trial in collaboration with UCSD in hopes of getting Modius approved by the FDA as an obesity therapy. A booth representative shared that 20 participants have been recruited so far, with an aim of at least 200 by end of 2018 and an ultimate goal of 300. (The actual ClinicalTrials.gov page lists n=60.) As part of the study, all participants receive four consultations with a nutritionist, half receive the real device, and half receive a placebo version. Dr. McKeown hopes to see Modius in the treatment pathway by mid-2019, and noted that the company is currently engaged in FDA discussions. A study for pediatric use is also being conducted, according to the booth representative.
  • The headset form factor is bulky at this stage, and is controlled entirely via an app, which can also be used to track session frequency and duration. Exercise and manually-logged food data can also be logged. Currently, session information is sent to the company for analysis, indicating that provider sharing may be a future feature.

3. Pharma Embraces Digital Health; Solutions from Teva Pharmaceuticals and Phillips/American Well with Potential Diabetes Implications

Leaders from heavy hitting companies like J&J, UnitedHealthcare, Teva Pharmaceuticals, and Phillips seemed to agree at CES: technology has a firm place in healthcare, not only in treating sick people, but also in R&D and prevention. As Ms. Sandra Peterson, Group Worldwide Chair at J&J put it: “the system of healthcare delivery is archaic… We can use technology to enable people to take better care of themselves.” For J&J, that means integrating technology into every facet of their business, particularly in R&D. Ms. Peterson noted that J&J’s massive breakthroughs regarding the science of disease could not have been possible without deep expertise in technology and the computational power, visual processing, and machine learning that exists today. Indeed, as Dr. Yechiel Engelhard, Head of Digital Health at Teva discussed, transitioning to digital R&D makes perfect sense for the pharmaceutical industry, allowing for faster and better drug discovery. (As an aside, drug discovery is actually a piece of what IBM Watson Health is aiding pharma companies with – AI Can sort through and prioritize drug targets faster than any human.) For Ms. Rebecca Madsen, Chief Consumer Officer at UnitedHealthcare, technology allows for richer data, allowing UnitedHealthcare to meet patients where they are with experience they’re already undertaking. Ms. Madsen cited UnitedHealthcare Motion, the program which provides users with daily financial incentives in exchange for meeting specific exercise goals. (We continue to wonder if a similar program could be used with CGM or BGM.) She also noted UnitedHealthcare is becoming a lot more sophisticated in its prevention efforts, leveraging big data to detect when individuals are likely to become “detractors” and guiding them away from an unhealthy or economically costly decision before they make it. For example, when a UnitedHealthcare member is about to make an appointment with a physician outside of the UnitedHealthcare network, the website provides three nearby in-network alternatives. Nice!

  • Beyond R&D, Teva is attempting to directly change the consumer experience with technology, tackling asthma first. As a chronic condition, asthma shares many similarities with diabetes, requiring daily management and accruing significant healthcare costs – $60 billion according to Dr. Engelhard. Teva designed a connected inhaler capable of tracking appropriate administration. By comparing an individual’s inhalation technique with a continuous readout of their lung function, physicians were able to determine when improved education was needed versus when a different dose or regimen should be prescribed. The data readout is incredibly simple – a yellow dot for the incorrect technique, a green dot for the correct. A similar device for injectables in diabetes would be quite interesting! If providers could clearly see whether their patients were injecting themselves correctly (if at all) against a CGM readout, the savings in time and cost and uncertainty could be big.
  • Mr. Jeroen Tas, Chief Innovation and Strategy Officer at Phillips and Dr. Ido Schoenberg, Chairman and CEO of American Well, discussed their upcoming digital solution with potential implications for diabetes. This quarter, the two companies will launch a system that allows parents to collect data from their baby leveraging a host of connected devices (e.g., a connected feeder). The data can then stream directly to a care system, which the parents can access 24/7 through voice technology – with just a press of a button, parents can speak to a physician for any reason through Alexa, receiving immediate care. In the background, the system checks for reimbursement, seamless integrating the entire healthcare system into one, intuitive experience. Could we see something similar in diabetes, integrating connected devices, video visits with a physician, and back-end billing? Medtronic does have partnership with American Well focused on delivering remote telehealth to complex, chronic, co-morbid patients – perhaps this isn’t so far off in diabetes.

4. Rigorous Clinical Trials for Digital Therapeutics; Getting Patients, Providers, and Payers on Board

“Digital therapeutics can and should be subject to the same kinds of trials as any other therapeutic,” noted Dr. Deborah Kilpatrick, CEO of Evidation Health. In fact, she argued, demonstrating the value of digital solutions is often easier, as they’re naturally “virtualizable.” Dr. Adam Kaufman, CEO of Canary Health, who focuses on diabetes self-management support (see our coverage here) highlighted Canary’s rigorous testing conducted in collaboration with Anthem and Stanford as “one of the largest digital therapeutics studies.” Canary’s six-week program was tested in a cohort of 1,300 patients with diabetes, demonstrating reductions in A1c, improved medication adherence and self-efficacy, and reduced depression. Dr. Kaufman also noted Canary’s soon-to-be-published study revealing substantial cost savings associated with the program. Mr. Joel Sangerman, Chief Consumer Officer at Click Therapeutics, which offers digital solutions for a slew of chronic conditions, echoed the importance of clinical trials in getting payers onboard. He’s found payers to be extremely supportive, and Magellan Health is Click Therapeutics’ largest investor shareholder. Ms. Eli Kaplan, CEO of Neurotrack, a company providing the first digital diagnostic test for Alzheimer’s disease, with a prevention program to launch this Spring, claimed that preventing two million people from converting to Alzheimer’s could save $30 billion per year. As noted by Mr. Sangerman, the FDA has been integral in creating an infrastructure for digital therapeutics. The Agency’s recently clarified regulatory pathway for Software as a Medical Device (SaMD), he said, has proved “very encouraging.”

5. Time Inc. Reveals New Virtual Reality Digital Health Solution in Collaboration with Framestore and Stanford

Although it was the very last session of the day, the room was absolutely packed to see a live demo of Time Inc.’s brand new virtual reality digital health solution. And for good reason! Developed in partnership with Framestore and Stanford University, LUMEN 2.0, is a virtual reality experience designed to relax the user in a matter of minutes. Users are immersed in a forest and are shown how to use their focus and breathing to “grow” the trees around them. It’s an incredibly personalized experience, as users can change the time of day, color scheme, and their own “height” to whatever they find most soothing. LUMEN 2.0 was first tested as part of Stanford Children’s Hospital’s Project Brave Heart. Dr. Walter Greenleaf, a visiting scholar at Stanford University with over 30 years of VR experience, described how children awaiting a cardiology surgery spend the weeks leading up to the procedure filled with immense dread. LUMEN 2.0 is currently being assessed to see if it can meaningfully reduce these children’s stress levels. While the data are still being collected, Dr. Greenleaf noted that a feature which allows patients to learn from virtual peers who have gone through the surgery has helped convince initially unwilling patients to undergo a particular procedure. Cool! We wonder if there are potential applications for diabetes with VR/AR. Imagine a similar virtual experience in which patients can watch what happens to their body when blood sugar levels are high? What about using virtual CGM or pumps to understand what they feel like? The stress reduction program alone could also be valuable for those with diabetes distress. How about a virtual image of a patient with prediabetes, progressing to diabetes unless things are changed? It can be difficult to take a disease seriously when its effects are invisible and promised to manifest years later – can VR help? As Dr. Greenleaf pointed out, VR in general has the potential to revolutionize healthcare, from prevention and wellness to training physicians to have empathy for their patients. There is a lot of enthusiasm in the mainstream tech press for using VR in healthcare, especially for physician training and pain management – see articles here (physician training, pain, rehab), here (mental health), and here (surgery, medical training, patient treatment).

 

-- by Maeve Serino, Adam Brown, and Kelly Close