Overview of Product Development

Development of decocare

The library was developed by via careful analysis of messages passed between Medtronic’s Carelink software, blood glucose meters equipped with the feature known as meter-link, Medtronic’s pump remote control, Carelink software, and the carelink usb stick.

Messages from the Carelink data management application software were analyzed for structure and semantics. Python code was then written to recreate the messages needed to successfully transfer data from remote equipment to a local application. The full logs and output from each experiment were captured in git for additional debugging and perusal.

The software includes a suite of tests. Many of the tests will prevent the software from running in an abnormal condition is found in the tests. The Carelink USB stick offers a facility for counting how many messages have been sent and recieved in error, corrupted, or successfully. All experiments capture the status of these counters at the beginning and end of each use to provide diagnostic information on the operation of the usb stick. This information can be helpful in determining if the protocol is exchanging messages as Medtronic intended.

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Please provide an overview of the product development, including an outline of nonclinical and clinical testing either planned or already completed. However, please note that our review of a Pre-Sub will not include a review of bench or clinical data that you have already collected.

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