Memorandum

Apple September 2018 Event – Watch Series 4 can take ECG, detect Atrial Fibrillation and falls; One Drop BGM direct-to-Apple Watch – September 12, 2018

Executive Highlights

  • Apple announced the Series 4 Watch yesterday, with a number of notable health updates: (i) the ability to take an electrocardiogram (ECG) right on the watch, which can detect atrial fibrillation (AFib) in just a 30-second test; (ii) an Irregular Rhythm Notification Feature, which runs in the background and identifies irregular heart rhythms suggestive of AFib; and (iii) fall detection (could be very impactful for diabetes). Notably, the ECG features received FDA de novo clearances (letters here and here), representing the first over-the-counter, direct-to-consumer ECG products ever. This also shows Apple working closely with the FDA, and indeed, the agency just put out a press release mentioning Apple as an example of its close work with digital health companies. (Apple is also part of FDA’s PreCert program.) Notably, AHA President Dr. Ivor Benjamin came on stage, calling the new Series 4 ECG feature “gamechanging.”

  • CEO Tim Cook repeatedly referred to the Apple Watch as “an intelligent guardian for your health,” and it was notable to see the Watch Series 4 introduced first yesterday – even before new iPhones. There was no mention of diabetes or non-invasive glucose monitoring yesterday, though Dexcom’s G6 Apple Watch app is shown in the health apps section of the Series 4 webpage. Apple seems more internally focused on heart monitoring with the Watch, leaving diabetes to partners.

  • On a related note, One Drop announced today that its new Chrome blood glucose meter will send data direct-to-Apple Watch, a first in the glucose monitoring field (i.e., no nearby phone needed). The new meter is $49.95 and starts shipping today. In iOS 12, One Drop will also launch Apple Health Records integration, enabling Experts coaches to see vitals, labs, and medications shared by users to Apple Health Records. Forward looking glucose prediction for type 2s not on insulin is still expected to launch later this month. One Drop was not mentioned on stage today, but is obviously a strong Apple partner.

  • Dexcom’s direct CGM transmitter-to-Apple Watch efforts were also not mentioned today. At Keystone, Dexcom CEO Kevin Sayer said to expect this sometime in 2019. Presumably One Drop has paved the way on the development side here.

Yesterday, Apple announced product line updates at its special September 2018 event. See the 1 hour, 47-minute stream here and key details below on Apple Watch Series 4 health features and One Drop’s direct-to-Watch BGM integration. New iPhone X models were also announced.

Apple Watch Series 4 – “An Intelligent Guardian for Your Health”

  • Apple announced the Series 4 Watch today, doubling down on the health, fitness, and heart monitoring focus we’ve seen in previous Watch iterations. CEO Tim Cook used the phrase, “Apple Watch has become an intelligent guardian for your health” multiple times, a great slogan and direction for Apple to go in – particularly on the cardiovascular monitoring front.

  • Apple Watch Series 4 has some new and very notable heart features, reflecting close work with the FDA and a definite focus on CVD.

    • Users can now take an electrocardiogram (ECG) by touching the Serie 4 Watch’s digital crown. The test takes 30 seconds and will inform users if a heart rhythm is normal or if Atrial Fibrillation (AFib) is detected. This is quite amazing to have built directly into the Apple Watch! Notably, this is the first ECG product offered over-the-counter, direct to consumer – no prescription needed and truly democratizing heart monitoring. FDA has categorized this feature as a Class II medical device, per the de novo clearance letter just posted online. A black slide during the talk simply showed “FDA” in white text, greeted with applause – and the app will be available on Apple Watch “later this year.” The FDA’s Drs. Jeffrey Shuren and Scott Gottlieb just put out a press release mentioning this new Apple Watch feature as an example of its close work with digital health companies. Of course, Apple is also part of FDA’s PreCert program, and this certainly shows impressive progress on that front. All ECGs will be stored in the Apple Health app, allowing patients to share them with providers. The feature is only cleared for those 22 years and over.

  • Notably, American Heart Association President Dr. Ivor Benjamin came on stage and spoke enthusiastically about the new ECG feature: “Capturing real-time data about a person’s heart is changing the way we practice medicine.” He later called the feature “gamechanging.” He read mostly off the teleprompter, but it was still a very big deal to have him on stage and supporting this new ECG feature – obviously not all cardiologists may not be excited about this initially, but we expect it could detect a lot of AFib.

  • Series 4 will also screen heart rhythms in the background –  if it detects an irregular heart rhythm, it will notify the user of possible AFib. This feature received a separate de novo clearance from FDA, also under Class II. The Irregular Rhythm Notification Feature is only cleared for those 22 years and over, just like the ECG app. We assume this leveraged the impressively cool Apple Heart Study (in conjunction with Stanford), which allowed Watch users to electronically enroll and be notified if AFib was detected. (Adam was part of this study and we feel it’s a real model for future virtual, very large-scale clinical trials to validate mobile medical apps/software.) The FDA letter does not indicate how many users were tested for this feature, but we imagine it was tens of thousands and perhaps more.

  • Series 4 will also deliver a notification if heart rate is detected to be abnormally low, building off the current Watch’s high-heart-rate notification.

  • Notably for people with diabetes, Apple Watch Series 4 can also detect a fall automatically. Apple did studies with “thousands of people” and analyzed real-world falls, understanding the hand motion patterns and building them into the Series 4’s new accelerometer and gyroscope. If the Watch detects a fall, it will display a message: “It looks like you’ve taken a hard fall.” If the user does not respond after a fall is detected, the watch will call emergency services – wow! This could be quite amazing for people with diabetes, especially older patients at high risk of severe hypoglycemia.

  • Similar to the Series 3, the Series 4 will come in cellular+GPS ($499) and GPS-only models ($399). Series 4 has a 30%+ larger screen that pushes to the corners of the watch, and Apple has managed to make it thinner too. Battery life is the same at ~18 hours.

  • Dexcom’s G6 mobile app for Apple Watch is included on the health apps section of the Series 4 web page, but was not mentioned on stage today. Still, it is great to see diabetes and CGM included on Apple’s website! The caption is a bit awkwardly phrased – “now test your glucose levels at a glance” – though we do love seeing “type 1 or type 2 diabetes.”

One Drop Chrome BGM direct-to-Apple Watch Integration

  • In long awaited update, One Drop finally announced that its Chrome BGM will send glucose values directly to the Apple Watch Series 2, 3, and 4. This reflects a first in the glucose monitoring industry – no nearby phone needed to send data to the Watch. The news comes about nine months later than the original hope to launch in 4Q17; still, it is definitely a major milestone as more and more functionality gets built into smart watches. The new Chrome BGM begins shipping today for $49.95. Since it required a firmware update to the meter, current users will need the new BGM for direct-to-Watch integration.

  • We’ll be fascinated to see how widely used this feature is in BGM –it could improve data capture and engagement with the One Drop app right on the Watch. Arguably direct-to-Watch is even more exciting for CGM users, who would not need a phone nearby to see their real-time glucose data. Combined with cellular in the Series 3 and 4 Watches, direct-to-Watch will also allow data to be send to the cloud without a phone nearby.

  • When iOS 12 launches next week, One Drop will also launch Health Records and Siri Shortcuts. With the former, users subscribed to One Drop Experts can grant their coach permission to view vitals, labs, and medications shared to Apple Health Records. Personalized Siri Shortcuts will allow users to log food moments and recall average blood glucose and percent in blood glucose range –entirely through a voice user experience.

  • One Drop will launch Automated Decision Support (ADS) for type 2 users not on insulin later this month, as expected following the initial ADA announcement and plan for a 3Q18 launch. As covered at D-Data and in an ADA late-breaking poster, One Drop’s ADS gives a forward-looking glucose forecast up to 12 hours ahead based on limited fingerstick data, food logging, exercise data, and other contextual inputs (e.g., demographics, weight, A1c). Initially, it will be available for people with type 2 diabetes not on insulin, with obvious potential to expand over time. One Drop’s ADA poster found 91% of the ADS model’s predictions were within 50 mg/dl of the future meter value, 75% were within 27 mg/dl, 50% were within 14 mg/dl, and 25% were within 6 mg/dl. The median error was 14 mg/dl, and the mean error was 21 mg/dl. The prediction was actually compared to the meter value whenever the next fingerstick was taken (majority were in the 2-12 hour range). This seems like strong accuracy for this population of non-insulin users, especially if 75% of predictions were within 27 mg/dl of the meter. Will it hold up in real-world use? We like that the feature includes lifestyle-focused tips for users, which could drive real impact in type 2s not on insulin.

 

 

 

--by Adam Brown and Kelly Close