FDA clears Telcare’s 3G blood glucose meter

By: Brian Dolan | Aug 1, 2011        

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Telcare Blood Glucose MeterAccording to an FDA filing, wireless-enabled blood glucose meter developer Telcare just received 510(k) clearance for its device, Telcare BGM. The company submitted its device for FDA review at the beginning of March.

Telcare has largely eschewed the glucometer-smartphone pairing model currently pursued by a number of other device makers in favor of a wireless meter “that requires no additional investment.”

Telcare’s device is cellular-connected and according to the company it is “merely a replacement of older technology for which insurers already pay.”

The Telcare BGM includes 3G cellular connectivity that send glucose tracking data to the company’s clinical server. Telcare is also developing a suite of smartphone apps, which might be used by caregivers, including “parents of children with diabetes and those caring for elderly people with diabetes,” to better manage their loved ones.

“Moreover, the Telcare blood glucose meter significantly increases the work productivity of disease management personnel who no longer need to spend time calling patients to ask for glucose data and can now relay simple coaching directly on the Telcare blood glucose meter platform instead of using less efficient means of outbound communication,” Telcare states on its website. The company says the device can send data directly to electronic health records (EHRs).

Telcare has previously stated that it plans to offer its blood glucose meter offering to customers at the same pricepoint of “disconnected” devices that are already on the market.

The company has raised about $4.5 million in funding to date from investors including Qualcomm Ventures. It also works with Sierra Wireless for its device’s connectivity. (Update: Sierra is not an investor in the company.)

Learn more about the Telcare executive team (led by Jonathan Javitt MD MPH) at Telcare’s site.

  • http://twitter.com/Qualcomm_Health Wireless Health

    Congratulations, Telcare team!!

  • tmana

    Once again, the patient has the monitoring responsibility, pays a monthly fee for wireless service connectivity, but the data go directly to the device manufacturer, and then to the healthcare provider — not the patient. How about giving the patient control over his own readings and information, and uploading the data to the patient’s PHR, to which he can allow ALL of his healthcare providers (not just his PCP or endocrinologist) read, copy, and comment access?

  • http://matthewtendler.com/ Matthew Tendler

    Tmana — you are absolutely right about that.  We at Telcare agree that the patient should have total control.  Actually, the data from your Telcare meter goes to your private page on MyTelcare.com and to your Microsoft Health Vault account, if you so choose.  Your data can be accessed by any doctor you decide to permit to access your data. Again, you, the patient has total control.  I have had Type 1 diabetes for about 9 years and I wouldn’t have it any other way.

    You are also right to object to a wireless health model where the patient has to pay more. There is no monthly fee or contract to sign for Telcare’s wireless connectivity. Those costs are included in the price of the strips which are comparable in price to the standard brand products and are insurance reimbursable. 

    Sincerely,
    Matt Tendler
    VP of Telcare, Inc.

  • tmana

    Thank you for addressing my basic concerns. I’m presuming the 3G connectivity will be through the major wireless carriers. Will there be issues in areas where one carrier is prevalent and the others weaker or not available, or is the device designed to be network neutral (working on both CDMA bands and on the appropriate GSM bands)?

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