J&J/LifeScan announces US launch of Bluetooth-enabled OneTouch Verio Flex BGM and updated, paired OneTouch Reveal app now compatible with Android – February 24, 2016

J&J/LifeScan announced this morning the US launch of its new Bluetooth-enabled OneTouch Verio Flex BGM and updated, paired OneTouch Reveal app. The company has already started shipping the Flex to US retailers, which is currently available online and will “soon” be available in pharmacies nationwide. The Flex replaces LifeScan’s former Bluetooth-connected OneTouch Verio Sync BGM (which has now been discontinued) and is priced quite reasonably at $19.99, cheaper than Roche’s Accu-Check Connect (now, the only other Big Four Bluetooth-enabled BGM on the market at $29.99). The updated Reveal app is available for free on Apple and Android devices – Android compatibility is a new feature – and remains the only Big Four connected meter to post data to Apple’s HealthKit (the Connect does not). As a reminder, the meter received FDA 510(k) clearance in July 2015 – so this was a relatively slow progression to commercialization – and launched in Canada, Germany, and France in 2015. Additional worldwide launches are apparently “in progress.”

Aside from Bluetooth connectivity and a smaller size profile than the Sync, the Flex is on the very basic side in terms of on-device features, headlined by LifeScan’s “ColorSure” technology: an arrow that points to a colored bar to indicate whether a glucose reading is low (blue), in-range (green), or high (red). The Flex has made some clear tradeoffs to keep the cost low, including a less readable black ink display and coin-cell battery power (and thereby elimination of the test strip port light). In our view, this is a case study in diabetes technology design tradeoffs. Would patients pay double the price for a meter with a color screen and more functionality? Probably not. J&J also gives meters away for free – like all the BGM players – so an expensive connected meter hurts margins at a time when they cannot go down further. Perhaps the goal here was to keep Flex’s cost as low as possible, retain the key feature of the VerioSync (Bluetooth), cleverly add a color indicator even with the black ink screen, and improve on the VerioSync’s size and frequent need to recharge. So while we were unimpressed with this meter at first glance, it does have an innovative niche and angle.

Ultimately, J&J’s US business has been extremely hard hit by BGM pricing pressures (in 2015, US sales declined 4% YOY to reach $833 million despite an easy comparison to FY2014 when sales fell 6% YOY), and this launch is a step toward more seamless, automatic, and hassle-free transfer of blood glucose data. The news is a win for patients – a branded, accurate, Bluetooth-enabled meter for just $19.99 – and at the same time, we hope to see much more ambitious BGM forays in the future. For instance, could J&J BGMs provide insulin-dosing advice like Sanofi’s MyStar Dose Coach or Glooko’s MIDS (both shown at ATTD)? What about a proven structured testing program like STeP integrated into the Reveal app? Could motivational real-time reminders and behavior modification recommendations be integrated via artificial intelligence? How can LifeScan connect the Flex and Reveal with products at Animas and Calibra for more compelling therapeutic change?

• LifeScan is positioning Flex’s ColorSure technology – see pictures below – as its distinguishing feature vs. other branded BGMs. The technology provides the intuitive ease of color association for interpreting blood glucose readings. We had expected the display to ‘light up’ in the appropriate color, though the meter instead uses a relatively subtle arrow to signal hypoglycemic (blue), in-range (green), and hyperglycemic (red) values. Still, management shared findings from a pre-launch survey demonstrating that 90% of patient’s thought the meter's color range indicator helped them easily interpret their blood sugar readings and 86% agreed that the color indicator improved conversations with their healthcare providers. Management spoke about the technology as a great solution for patients who struggle to understand numerical values; this certainly makes sense though to better understand the commercial implications, we would love to know what fraction of patients have problems with numerical literacy, and to what extent is the color helping them take action based on the reading? The color indicator will presumably be more useful for non-insulin-using patients, who are less likely to need the granular numerical display to make therapeutic decisions.
  
  • LifeScan’s marketing message is one of convenience (“Take the guesswork out of your numbers”), which is no surprise considering how the company has stressed the intuitive ease of color association for interpreting blood glucose readings in recent exhibition halls (ADA 2015; EASD 2015; IDF 2015).

ColorSure Indicator

• We hope that glucose-color associations become standardized across industry. The Flex labels hyperglycemia “red,” which we admittedly found a bit misleading – red is typically reserved for immediate action and a danger sign (e.g., hypoglycemia). Every company does this differently, though we hope it can become standardized.
• Flex has a similar stripped down user interface (only three buttons), which does not bog users down in lots of menus. The addition of the coin-cell battery also removes the hassle of recharging, which is a pain with the VerioSync and VerioIQ. The next-gen Flex is based on the OneTouch Verio strip platform, so we don’t anticipate the discontinuation of the Sync meter will present a problem for current Sync users.
• The Flex runs on a coin-cell battery and aims to conserve battery life through the elimination of lighting in the test strip port. This is a tough tradeoff, and we assume patients will be mixed on this front. Test strip port lighting is a key feature for many that enables testing at night and in a variety of other settings where adequate lighting may be an issue (movie theaters, camping trips, planes, power outages, etc.). On the other hand, would patients pay more for a rechargeable meter with a port light?
• We were hoping LifeScan would upgrade from the VerioSync’s backlit black-and-white display to a color display.  Instead, the Flex has gone to a less readable ink display. We assume this was a deliberate decision for cost and battery power tradeoffs, which makes sense..
• On the connectivity front, the new OneTouch Reveal app has a much-improved user interface and a better one-page overview with key information. The app’s main page provides a snapshot of the most recent glucose reading, the average number of tests per day, and an overview of 14-, 30-, and 90-day blood glucose patterns that include percent of readings in hypoglycemia, in-range, and hyperglycemia (these cutoffs can be customized). Subsequent pages include a color-coded logbook that stores a full year of glucose values and a pattern-detection feature that identifies trends of hypoglycemia and hyperglycemia. Clicking on a pattern gives a deeper dive into the events that triggered its identification.
  
  • Glucose readings can be sent to parents and caregivers by text and email, sending a comprehensive report, or exporting CSV data. It is a nice feature and we wonder if it could be automated in subsequent iterations.
  • Importantly, the Reveal app remains the only Big Four connected meter to post data to Apple’s HealthKit (Roche’s Accu-Chek Connect does not). We are glad to see that the company’s next-gen meter continue to leverage this capability as it offers the potential for other apps like Glooko, mySugr, Meal Memory, and OneDrop to pull the readings automatically and combine it with other data (e.g., exercise, meals, insulin doses).
• Of course, a major caveat to connected devices is the accompanying rise in patient expectations – the user experience on a phone is expected to be world class, and early adopters have graded connected device apps harshly. The OneTouch Reveal app has a cumulative 2.5/5 stars (n=285); the newest version of the app has 2/5 stars (n=4). For context, Roche’s Accu-Chek Connect app has 2/5 stars (n=9), iHealth’s Gluco-Smart app has 3/5 stars (n=87), and Dexcom’s G5 app has 3/5 stars (n=32). The leading connected device app on the iPhone is Medtronic’s MiniMed Connect with 3.5/5 stars (n=55). In our view, patient perception will become more positive once these apps move from basic pattern recognition functions towards creating valuable, data-driven features such as insulin dosing advice (e.g. Sanofi’s MyStar Dose Coach, Glooko MIDS, DreaMed MD Logic Pump Advisor) and photo-based meal tracking (e.g. Meal Memory and Nutshell). For that, we look forward to device companies working with the FDA and potentially partnering with external software developers to bring truly compelling offerings to market.
• We were also intrigued to learn more about the timeline over which the OneTouch Verio Flex System has received clearance and launched. The system is already available in Germany, France, and Canada (CE Mark in January 2015) and additional worldwide launches are “in progress.” As a reminder, the Reveal app has been available since the launch of the Verio Sync BGM (January 2014) and we wonder how many times it has been downloaded to date.

-- by Ava Runge, Varun Iyengar, Adam Brown, and Kelly Close