Some of us have been waiting a long time for a bluetooth blood glucose meter. Almost all cell phones and computers sold today support Bluetooth technology that lets us connect devices like blood glucose meters without using any wires.
Three different bluetooth standards permit connections between devices separated from about 1 meter to about 100 meters. In the past two and one-half years I’ve been so exciting about the prospect of automatically connecting our meters to cell phones and computers that I’ve written about three companies that promised us bluetooth meters.
Just like cures for diabetes and wonder drug that will let us perfectly control it, many of the announced devices never make it through the U.S. Food and Drug Administration and come to market. As far as I have been able to determine, theGlucoTel device that I wrote about in Diabetes Health magazine in October 2006 didn’t make it here.
I am also still waiting for two other bluetooth meters. A year ago I wrote here that Confidant Inc. will let people send blood glucose, blood pressure, and weight measurements to their heath care providers using their bluetooth-enabled cell phones. Last April the people at AgaMatrix told me that they are making a separate version of the Jazz that will include Bluetooth wireless capability.
While I jumped the gun on those three devices, one bluetooth meter is now finally available. A month ago the FDA gave Entra Health Systems in Alpine, California, its stamp of approval for the company’s MyGlucoHealth Blood Glucose Monitoring System. The government’s stamp of approval for this and most meters is technically a Section 510(k) premarket notification. “The FDA finding of substantial equivalence of [this] device to a legally marketed predicate device …permits [the] device to proceed to the market.”
The First Bluetooth Meter in the U.S.
The people who make this new meter call it state of the art, and I agree. Just for starters it lets us connect the meter with our PCs either via Bluetooth or USB and to cell phones via Bluetooth. But I also don’t know any other meter that uses a smaller blood sample than the MyGlucoHealth’s 0.3 microliters or gives us a result faster than its 3 seconds. Of course, that means we can use it on alternative test sites, like our arms, where we have few nerve endings.
And like more and more meters nowadays it automatically codes test strips, so it’s a “no coding” meter. While the product literature that Entra sent me doesn’t mention it, the manual says that you can delete test results. This is useful when you know the results are wrong, but many meters that don’t trust us don’t let us do that.
The MyGlucoHealth meter is fully compatible with Bluetooth phones on AT&T and Blackberry devices on all networks. Entra is finalizing compatibility with Verizon.
The Entra Health Systems website for the MyGlucoHealth is http://www.myglucometer.com/. “We are in the process of securing retail partners and should have a comprehensive list in the next few weeks,” Entra’s Chairman John Hendel tells me. “Meanwhile, the units will be available on line now via request and will have an online shop set up in the next few weeks. The retail price is $99 for the meter kit which includes the meter, USB cable, lancing device, 5 lancets, 5 test strips, and free web access. The strips are retailing for $49 for 50 strips.”
If you are one of the people who have been waiting for the latest technology, these are the people to contact.
This article is based on an earlier version of my article published by HealthCentral.
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Do you know if the GlucoTel was resubmitted to the FDA for 510k clearance? And, why it didn’t make it the first time?
Sorry, but I don’t know. Anybody else?
It’s available for purchase now at http://www.myglucometer.com
You can follow us on Twitter at http://www.twitter.com/myglucometer
Have a great day!
The best thing for you to do would be to contact the manufacturer at http://myglucohealth.net/contact.asp
Any idea where this meter can be purchased online?
I spoke with John Hendel and he’s going to let me explore the web site. He did let me know that the data is extracted in XML format and can be uploaded to their website for use by the patient or clinicians.
Sorry, but I don’t know. Anyway, you are more of an expert on that sort of stuff than I am!
Finally, the first of a new breed. David do you know anything about the data formats or whether the data can be extracted from the software?