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FDA Approves WellDoc Smartphone Mobile Diabetes Tool/Software Using Bluetooth And Automated Algorithmic Analysis Processes

Posted Aug 03 2010 1:15pm

Back in April of 2008 I wrote about the pilot program being conducted with Blue Cross for this application and you can read more at the link below.  A short clip from the original post follows.  image

“260 patients will be a part of the program and I guess they will all need to have or will be supplied a cell phone to participate, information goes to the physician and to the payer for study of the results and may connect to a live person who is assigned to coach and connect immediately upon troubled information...it will remind you to enter the information and the information on the patient readings goes to the phone from the Blue Tooth device used to create the readings...and if things are out of line a virtual coach comes on immediately with additional information to contact your physician or will provide formatted help on how to avoid a reoccurrence.”

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This is also something to be aware of with FDA device approvals having health insurance trials via use of software.  We are seeing all types, sizes and kinds of Wellness programs.  Alerts are sent via cell phone and the coach has some interactive roles.  A blue tooth connective device that takes the glucose readings automatically send the readings so if this method is used, no data entry from the patient. 

The decision making algorithms help the patient with automated information analyzed to make more informed decisions.  There’s that word once more, the algorithms” and the reason I have placed the word and it’s meaning on the middle of this blog.  As with any program of such ask questions as to where your data is stored and who has access.  WellDoc states all information is stored on their servers. 

The program states the automated processes creates a “virtual endocrinologist” with information provided.  BD

The Food and Drug Administration has given 510 (k) clearance to the mobile phone-based DiabetesManager System of WellDoc Communications Inc.

The application enables Type 2 diabetic patients to enter their blood sugar readings into their mobile phone and receive real-time feedback on what they should eat and other ways they can help stabilize their blood sugar. The software also can alert patients when they need to test their levels.

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Further, the application sends the data to the vendor's servers, where it is analyzed and can be accessed by the patient's physicians and disease management caseworkers. It also can support glucose meters that can send data via Bluetooth wireless technology.

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