Medical device manufacturer DexCom over the weekend announced the company is developing an app for the upcoming Apple Watch that will display all of a user's glucose and blood sugar-related health data on their wrist (via The Wall Street Journal).
The company, whose expertise lies in "continuous glucose monitoring systems for diabetes management," says the app is expected to be ready when the Apple Watch launches in April. The app would sync to existing monitors manufactured by DexCom that use a "hair's width sensor" located under the user's skin to measure and report blood glucose levels every five minutes, a more seamless process than traditional skin-prick glucose monitors, according to the company.
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Though most health-related apps have been closely scrutinized by the FDA in the past, The Wall Street Journal reports DexCom and a group of developers behind another diabetes-related application called NightScout have convinced the FDA to change course on health apps.
The group’s effort challenged the slow pace of innovation and regulatory approval in the field. It also highlighted the growing role that Silicon Valley companies and software developers hope to have in monitoring and maintaining people’s health.
Previously, the FDA considered glucose monitors and any associated software to be Class III medical devices, meaning they received the highest level of regulatory scrutiny. But the spread of NightScout, the system developed by the group of software engineers, and DexCom’s submission of a separate iPhone app for review prompted the FDA to change course last month.
Subsequently, DexCom's monitors that require injection under a patient's skin will understandably remain Class III devices but the software that displays the data - such as the Apple Watch app - now only needs to be registered with the FDA without prior marketing approval. Alberto Gutierrez, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, evoked the positive benefits of the app far outweigh any negatives, “We felt that the risks that the app imposed weren’t as high."
Apple itself has been steadily moving towards a more health-concerned future, with the introduction of the Health app into iOS 8 as a preparation for the upcoming built-in fitness integration features of the Apple Watch. Major U.S. hospitals are rolling out their own trial programs with HealthKit, Apple's tools that leverage the iPhone's various motion-tracking sensors and peripheral accessories to track and log the history of a user's health data.
Top Rated Comments
(View all)Where do you get the sensor implanted under your skin? At the Apple store?
That's where I got my Apple Pay barcode tattoo.
Sadly, this is only tracking software. My meter does this already, and my doctor downloads the data from it. I don't see this changing anytime soon, considering medical devices have soooooo much regulation.
The Dexcom system is not just tracking software. It's a Continuous Glucose Monitor (CGM) via a sensor the user implants under the skin that reads your BG every 5 min.----------
Where do you get the sensor implanted under your skin? At the Apple store?
No LOL - the user implants the sensor. FDA says to change it every 7 days but I typically get 20+ days out of mine. The Apple Watch and the Dexcom system are mutually exclusive. What is being integrated is the option for the transmitter to send the data now to other devices (i.e. Apple Watch, Android phones etc) and not just the receiver we all have currently to see the data.Here's your quandary.
Here's another quandary:You're diabetic. You have a blood glucose test unit for £10.00
You can continue using it like you always have done or spend £400 on a watch(!) to do the same thing.
Or.
You're not diabetic. But have a sudden interest in monitoring your blood sugar or other people's - now the Apple Watch has come out.
Either way. Go for the former option. Honestly. It'll save you much money. £390 more money. Sorted! Next problem?
You're not a diabetic, so your pancreas works, and you have a closed loop system to control your blood sugar. You decide, tonight, to eat a piece of cake with 39g of carbohydrates, and then go to sleep. You wake up, and your blood sugar is 72 +/- 10 mg/dl.
or
You are a T1 diabetic, and so you have to do all of those calculations in your head, or your insulin pump, but in the interest of saving money, you use shots and regular/NPH insulin, instead of a pump ($7000, plus $40/week in supplies and insulin) and a CGM ($1400, plus $50/week), supplied by Dexcom, since Apple isn't making a CGM, just a watch to see the results of that CGM on the watch. You wake up (or not) with blood sugar between 30 and 400, because your carb:insulin ratio didn't take into account the stress you had remembering the foxtrot on the dance floor, the dawn effect, the syringe you used didn't have the resolution needed to give yourself 4.8 units, or that the NPH kicked in after the sugar wore off of that cake, or some reason you didn't take into account, like over/underestimating the carb/fat/protein ratios and the glycemic index of that cake and your body.
Oh yeah, that 10 quid was for the meter. The test strips are still $1/ea for the OneTouch Brand. The meter companies don't lose money, and the meter is a loss leader. Ever try to get the Bayer meter to read a OneTouch Strip?
Come over to my house. I'll let you walk a mile in my shoes.
NOTE: Bruce did apologize for his post. My apologies for this rant after his apology.
Great...you've identified a feature/benefit that a vast majority of the population will never use. That's not going to be the way to sell me the watch.
Agree that this doesn't apply to the majority of folks out there (thankfully) but it's not really a "feature" of the watch. It's basically just another app. Even if I don't buy an Apple Watch the integration with my iPhone is still very exciting news for CGM users.
If you had a dead pancreas you would understand :)
:D All joking aside, how do you insert the sensor under your skin?
No worries and I laugh about this stuff all the time. Type 1 (Juvenile Diabetes) is pain in the ass but there are a lot of other folks a lot worse off than me.
There is an insertion device that comes with each sensor. Basically the sensor is wrapped around a needle which is inserted under the skin and then the needle is removed just leaving the sensor embedded. Very cool stuff and useful BG trending information for us.