When I first wrote about Medicare’s guidance in covering the Dexcom G5 Continuous Glucose Monitor (CGM), I was concerned about some wording that suggested that Medicare would not allow the use of a smartphone as a secondary display.
“An exciting nugget of information for Dexcom users was hidden among more eye-catching announcements during yesterday’s Keynote Address at Apple’s WWDC (Worldwide Developers Conference) in San Jose. Near the end of his preview of the upcoming watchOS 4 software update for Apple Watch, Kevin Lynch (VP of Technology at Apple) briefly showed a slide that included Dexcom’s CGM watchface. He stated (19:45 into the keynote address):
“We are also now supporting native core bluetooth on the watch, which is going to enable experiences for apps that work with small devices around you. So for example, continuous glucose monitoring directly from Dexcom’s sensor… to your watch.”
Similarly, Apple provided an information page which again specifically referenced continuous glucose monitoring as a beneficiary of the Watch’s upcoming software update (free for all Apple Watch owners, scheduled for this Fall).
What this means: iPhone no longer required!
As we predicted about 18 months ago when watchOS 2 was announced, the upcoming Watch OS4 software update will finally allow the Apple Watch to display CGM data without an iPhone nearby. Going for a run? You can leave your iPhone at home. Going on a flight? You can leave your iPhone in airplane mode.
Keep in mind that owning an Apple Watch still requires owning an iPhone, so Android users can’t just go buy an Apple Watch for use with their Dexcom CGM. (Android support for Dexcom should be here any day now, though). But this new feature does allow users to be separated from their iPhone for periods of time without losing access to their CGM data.
This also (likely) means faster CGM data on Apple Watch
Although not explicitly stated, I predict that watchOS 4 will allow CGM data to be refreshed faster on the Apple Watch since it will be pulling data directly from the Dexcom transmitter. The way it currently works requires data to be sent from Dexcom -> iPhone -> Watch, so removing the middle man should make for faster synchronization.
All that being said, Dexcom owners with Apple Watches can look forward to a better CGM experience with the free watchOS 4 software update scheduled for this fall.
News broke earlier today from CNBC’s Christina Farr that Apple, Inc. has a small team of engineers working on creating sensors that can “non-invasively and continuously monitor blood sugar levels to better treat diabetes”. The project is allegedly far enough along in development that Apple is investigating possible regulatory pathways and performing feasibility trials at clinical sites in the Bay Area.
The article suggests that the project is a wearable sensor (either inside or worn in conjunction with a future version of the Apple Watch) that can track blood sugar non-invasively with optical sensors, similar to how the current Apple Watch can monitor heart rate. Such a non-invasive continuous glucose monitor would undoubtedly be a “holy grail” for diabetes, but can Apple succeed where so many other companies have so far failed to deliver?
Just for fun, let’s brainstorm potential possibilities for what this secret Apple Project could be. We’ll sort them by order of plausibility.
Most Likely Possibility: Health-focused Apple Watch “Pro” with an Invasive Glucose Monitor Partner
One question underlying this whole scenario is whether or not Apple really wants to be a medical device company. As Tim Cook himself pointed out to The Telegraph in November, 2015: “We don’t want to put the watch through the Food and Drug Administration (FDA) process. I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it — maybe an app, maybe something else.”
Interestingly enough, he does mention the possible for an Apple-made companion device or software to the Apple Watch that might be a health device.
That being said, systems that closely resemble non-invasive continuous glucose monitors exist or are on the horizon. The Abbott Freestyle Libre Flash is approved in Europe for continuous glucose monitoring in diabetes, and does not require any calibration with a glucose meter. (A short-term version called the Abbott Libre Professional is FDA-approved in the USA).
Similarly, Verily (part of Google) has partnered with DexCom to work toward a penny-sized continuous glucose monitor that would be usable for both Type 1 and Type 2 Diabetes and not require calibrations.
Also, implantable CGM should be here soon (Senseonics is currently filing for FDA approval), which is inserted under the skin and worn for 90+ days.
The common thread with all these devices is that they are invasive and all require some sort of display/reader to receive the readings.
Apple could potentially create an FDA-approved Healthcare-focused (as opposed to just fitness) Apple Watch “Pro” that is more robust and can communicate reliably with such sensors. If the wireless connection and stability of the device were medical-grade, removing extra middle-man devices would be a huge boon to patients. Users of such a “Pro” Watch might sacrifice some other features (small size?) or not get a model updated every year, but it would be reliable enough for medical use. (Such a health-stable PRO Watch would be quite useful for Artificial Pancreas projects too).
Most Interesting Possibility: Consumer-grade Optical (or Microneedle) Glucose Monitoring for Everyday Use
Combining my theory that Apple does not want to become a medical device company and the fact that accurate non-invasive glucose monitoring is a feat of titanic proportions, perhaps their top-secret glucose monitoring project is not for medical use at all.
As society becomes more health-conscious and sensor-driven, it’s only a matter of time before the general population starts monitoring glucose. In the diet and nutrition communities, sugar and carbohydrates have become the enemy, and some athletes (without Type 1 Diabetes) actually use invasive continuous glucose monitors while training to optimize their diet and exercise regimens.
Companies like Sano have been working toward non-invasive CGM for everyday use, and Apple has acquired companies (eg C8 Medisensors) working on various forms of non-invasive CGM. Some of these companies utilize optical sensors, and others use an array of microneedles to sample interstitial fluid.
With consumer-grade CGM, people could observe rough trends about their blood sugar. They’d be able to see first-hand how quickly certain foods (eg. cereal, white rice) can spike blood sugars, and how avoiding carbs can keep blood sugars relatively flat. Furthermore, widely prevalent sugar monitoring might not be accurate enough to dose insulin or diagnose diabetes, but it could help raise awareness and promote screening for Pre-Diabetes.
As an endocrinologist without diabetes, I’ve had the opportunity to wear CGM’s in the past, and they have been very enlightening. If I had the choice, I’d wear quite often.
Moonshot Possibility: Medical-grade Non-Invasive Glucose Monitoring for Diabetes
Now this is clearly what the original source is suggesting, but I also find it the least likely. The article itself recognizes the immensity of this challenge:
“Accurately detecting glucose levels has been such a challenge that one of the top experts in the space, John L. Smith, described it as ‘the most difficult technical challenge I have encountered in my career.’ The space is littered with failures, as Smith points out, but that hasn’t stopped companies from continuing to attempt to crack this elusive opportunity.”
Much like Verily’s partnership to measure glucose levels via a smart contact lens, a non-invasive continuous glucose monitor from Apple would be mind-blowing. However, the diabetes community is well-aware of other longshots that have promised much, but never delivered. (Exhibit A: the GlucoWatch).
In addition to the technical challenges, I’m also not sure what Apple’s end-game with such a medical device would be. Would they try to carve out their own niche in the diabetes glucose monitoring space, taking on Dexcom and Medtronic? Would they license their technology to these companies? Would they try to market directly to consumers?
All that being said, I am extremely excited that Apple is focusing their efforts and resources on glucose monitoring and diabetes. I can’t wait!
The App Store is crowded with diabetes apps for both iPhone and Android, but how do you know which ones to choose? That’s why we tested them out and created a list of our favorites.
MyFitnessPal (iPhone, Android) – For Tracking Nutrition/Carbohydrates
MyFitnessPal (Free) is the most popular health app of all time, and for good reason! It has the largest searchable food database, with over 5 million different items, from home-made recipes to fast-food chains and restaurants.
But it’s also one of the best diabetes apps available. Users can track their nutrition for the purpose of weight-loss and/or counting carbohydrates. It’s like carrying a Calorie King guide in your pocket, but it’s searchable and constantly updated.
To simplify the hassle of logging food, MyFitnessPal can even use your smartphone’s camera to scan barcodes and instantly record nutrition information!
MySugr (iPhone, Android) – For Monitoring Diabetes
Built by a team of people with diabetes, MySugr (Freemium) is an adorable app that helps users log their sugars, carbohydrates, and medications. This app features statistics and graphs, including an estimated hemoglobin A1c that updates as you record your sugars.
Like all the other diabetes apps in this article, MySugr includes support for Apple Health, meaning that glucose data can be imported automatically from newer wireless glucose meters like the Accu-chek Connect.
For $2.99 each month, Pro Mode adds reminders to check your blood sugar and the option to generate PDF and excel reports for your doctor’s visits.
Diabetes Kit (iPhone, Apple Watch) – For Monitoring Diabetes
Similar to MySugr, the creator of Diabetes Kit (Freemium for iPhone) built the app on his own to help keep track of all his various numbers such as sugars, medications.
The unique aspects of Diabetes Kit are its companion Apple Watch app and its number-driven user interface, with multiple useful graphs and dashboards to help learn from your data. Unfortunately, unlike the other diabetes apps listed here, Diabetes Kit does not include a feature to estimate A1c.
Also similar to MySugr, $9.99 a year unlocks Pro Mode, which includes reminders and the option to generate PDF reports.
Sugar Streak (iPhone, Apple Watch) – For Motivation to Check Sugars
Sugar Streak (Free) is great for people who have a hard time remembering to check their blood sugar. During setup, users pledge to check their sugar anywhere from once to four times each day.
By recording their sugars and fulfilling their pledge each day, users build a sugar streak! As their streak gets longer without being broken, they earn points more quickly, and the points can be redeemed towards small prizes like gift cards.
Meanwhile, the app creates a glucose logbook with real-time statistics like estimated A1c, and can generate reports to assist with future doctor’s visits. Unlike the previous two diabetes apps, Sugar Streak does not track activity/nutrition/medications.
Disclosure: I am the creator of Sugar Streak.
These are just a few of our favorite apps for managing the various aspects of diabetes. While using a diabetes smartphone app might not be for everyone, we think many of our readers will enjoy at least one of our suggestions. The quality of diabetes apps have a come a long way from just a few years ago, and they should only continue to improve!
In a highly anticipated move, Roche released a software update to the Accu-chek Aviva Connect iOS app introducing Healthkit support to their wireless glucose meter. As previously discussed, the integration of Healthkit within meters from the two biggest glucose meter manufacturers (Roche Accu-Chek Aviva Connect and the Lifescan Verio Sync) signals a key turning point in the evolution of the smartphone’s role in managing diabetes.
Through Apple Healthkit, many third party apps now have access to glucose readings without the need for manually typing blood sugars. In addition, syncing through the phone simplifies the transfer of diabetes data from patient to provider or from patient to family member.
From a first glance through the app, users are automatically asked to allow permission for the Accu-Chek Connect app to write their blood sugars and carb counts to Apple Health.
Some advantages of the Accu-chek Connect over the Verio Sync is that the Accu-Chek meter includes a cloud-based diabetes management portal where users can grant access to their provider for real-time monitoring of their sugars. Also, the Accu-Check Connect uploads sugars to the cloud without requiring the iPhone app to actually be opened.
We’ll post more thoughts in a thorough review later.