It is quite possibly a new era in blood glucose monitoring! This morning, the FDA approved Sanofi-Aventis’ groundbreaking iBGStar product, the first and only BG meter that connects directly to your Apple iPhone or iPod touch. No cables are necessary, as this little meter sports an Apple-compatible plug built right in!
The iBGStar is already available in Germany, France, Switzerland, the Netherlands and Italy — and I am one of the first lucky U.S. patients to have my hands on one, as the developers provided me a review unit a few months ago. It truly is revolutionary to see your smartphone transform into a device that physically impacts your health.
There’s no word yet on how long it will take for iBGStar to actually go on sale here, but the company just made the U.S. website for iBGStar live this morning, complete with a cute little commercial video and product details. Check it out at www.ibgstar.us. You can sign up for updates.
“This is a momentous occasion,” gushed Shawna Gvazdauskas, Vice President and Head of Devices of Sanofi’s US Diabetes division over the phone today. “Obviously we’re as excited as you are, but I can’t disclose any details at this early stage. We’re not issuing any statements yet, but I can say that a ‘generic’ announcement was made at the mHealth conference (in Washington, DC) today.”
The FDA approving a medical device that plugs directly into a smartphone — and a consumer communication platform — is indeed groundbreaking. This paves the way for all sorts of phone/mobile/medical innovations.
So will the iBGStar and accessories like cases actually be sold in Apple stores around the country? Shawna couldn’t say. “That’s still up in the air. We’re working on commercialization strategies,” she told me.
I for one am very excited and VERY ENCOURAGED by this development; perhaps FDA is not as paralyzed on medical device innovation and technology integrations as they’ve appeared to be! This bodes well for all things diabetes, I believe.
Ever devil’s advocate, industry analyst David Kliff of Diabetic Investor (who alerted us to the news) takes a more measured approach:
“With this approval we’ll finally see if iPhone users who also have diabetes will favor a meter that works with their phone or will they remain loyal to their existing monitor. Although the iPhone is wildly popular and the iBGStar will certainly have the ‘cool’ factor, this does not solve some of the fundamental dynamics of the BGM market. Sanofi still must get the system on formulary and make the cost on par with existing systems. While there will a sub-segment of the market that will pay for the iBGStar, after all people have been known to stand in line for hours waiting for the latest version of the iPhone, the iBGStar as cool as it is just a glucose monitor.”
Yup. I can just see some of you running for your lawn chairs now — getting ready to camp out in front of the iBGStar store!


Sooo…..does this mean we can get insurance companies to cover iPhones? Not meaning to be too snarky….I guess that’s just my smart phone envy talking
Nice, I would love to get one of these guys through insurance.
I am SO excited for this!
WHOA! THIS WOULD BE SO COOL!!!!
My original thought process still holds true: why are these not WIRELESS devices. Bluetooth anyone?
It’s not 1999 anymore. I could play Pong wirelessly on my Palm V back then via IR.
CAN’T WAIT!!!!!!
Now we need an app that replaces the pump, and provides continuous glucous monoitoring.
Now we need an app that replaces the pump, and provides continuous glucous monoitoring.
DITTO-
and put the Strip makers out of business..
Interesting, the only thing is with so much “under the hood” of our phone they will start charging us $20,000 for one and set us up with routine checks every three months for $60. Then force us to have insurance on the device…
Why such a pessimistic view? They (whoever they are) won’t start charing us $20,000 for a phone because you and I both no that does not lead to financial success. There are other options.
I was kidding man, actually a complement at how advanced the devices have become. It always is in the interest of a product to be in reach of the buyers.
Indeed cool. Remember though that this was done back in the day by Therasense with Freestyle Tracker module in a Handspring PDA. Just before it’s time and before the advent of apps.
My 14 year old has and iphone and I can just see him getting all kinds of excited about this. Anything that makes diabetes exciting is worth its weight in gold in my book!
I played with one of these a while ago. AgaMatrix has done an excellent job with styling and integration. I’m so glad it’s finally on the market. Now I’m waiting for an Android version.
Amy, what type of AgaMatrix test strips does the iBGStar use? Hopefully the Jazz strips, they’ve worked really well for me so far.
[...] brought the T:slim, iBGStar, iPro2, and the [...]
Very cool, but I’d rather have my existing Dex and pump meter/remote send data to my smartphone.
the best part of this for me is that it looks like the FDA is no longer frozen and is reviewing and approving some devices for us. Like the previous posters I would make sense to me to simply use Bluetooth to send the data to the phone. Basically an APP – but who will develop said app if its not linked to the revenue from required new fancy strips ?
Wahoo! I’ve been waiting for this day. I just got the announcement this morning from iBGStar and was just about to send it your way, Amy. I see you’re already in the know.
Curious about the price point. I’ve offered to be a beta site. ; ~ )
I have to say, I have not been this excited since I got my iPhone 4 last year. This is great news! Finally diabetes devices are entering a modern age.
I don’t really get why this is considered “groundbreaking” or “a new era.” There’s really nothing different about this. I’m still pricking my fingers 10 times a day. The readings are just being transmitted to a different hand held device. I don’t mean to be overly negative but I thought it was some kind of no-prick testing device at first, so I was just a little underwhelmed when I realized what it was.
Because the readings are being pulled into the iPhone where they can be shared, analysed, charted etc. instead of just sitting on a piece of crap device that was cutting edge about 20 years ago.
OOOOO yes thank you thank you
Nice that the FDA is approving wireless devices, but this one is not for me. I already have a meter that transmits data to my pump. This won’t do that. Using this good looking device takes me one step away from full integration of my devices. Not the direction I want to go.
When the iPump arrives, I’ll be camping out.
While this is a great breakthrough I am still waiting for a device that integrates insulin delivery into the iphone. I currently use a BG monitor that also delivers insulin wirelessly through my pump. Add this technology and we truly have something great. One day at the lunch table I was delivering insulin via my monitor and I was asked if I was checking emails. If that integration is ever developed we would have something to rave about.
John,
I doubt cell phone manufacturers want to wait 5 years for approvals each time they update the system firmware of create a new design. Apple is a consumer electronics company, not a medical devices company.
[...] Shawna Gvazdauskas, Vice President and Head of Devices of Sanofi-Aventis, the developer of the iBGStar, noted in a phone call conducted by Diabetes Mine: [...]
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[...] SVP Devices, Sanofi-Aventis, the manufacturer of the iBGStar, said in a telephone call from Diabetes Mine [...]