Insulin Pump: Wireless insulin pump receives FDA clearance.

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Below is the un-edited press release from Medtronic MiniMed. It describes a recent project Omnica Corporation (www.omnica.com) contributed to for Medtronic MiniMed, Inc. Working with the Medtronic MiniMed, Inc. project team, Omnica performed a vital role in the development of the 500 series insulin pumps featured in this press release. 


Our input included design, engineering, prototyping, component validation, and documentation of the glucose management device. Read how we helped with the Minimed Paradigm project.




New “Intelligent” Insulin Pump and Glucose Monitor System Automatically Calculates Complex Diabetes Math – Recommends Insulin Dosage to Help Improve Patients’ Health


Paradigm infusion pumpNORTHRIDGE, Calif. – July 7, 2003 – Medtronic MiniMed, the diabetes management business of Medtronic, Inc. (NYSE: MDT), today announced United States Food and Drug Administration (FDA) clearance of the world’s first “intelligent” insulin pump and glucose monitor system, which helps remove the guesswork in insulin dosing, making it easier for patients to manage their diabetes. The wireless system, comprised of a Medtronic MiniMed Paradigm® 512 Insulin Pump and a Paradigm Link™ Blood Glucose Monitor, co-developed with BD (Becton, Dickinson and Company) (NYSE: BDX), has been launched nationwide.


This integrated system combines and simplifies two important steps in diabetes management, blood sugar (glucose) monitoring and insulin dosing, with the goal of helping patients keep their blood sugar levels within a normal range, which can lead to improved health and extended life for many patients. Using wireless technology, the Paradigm Link monitor automatically transmits a blood sugar reading to the Paradigm 512 insulin pump. The pump’s Bolus Wizard™ calculator performs “diabetes math,” recommending the proper insulin dosage based upon information preset by the user.


"This new integrated pump and monitor system is a major breakthrough in diabetes management," explains Bruce Bode, M.D., FACE, medical director, Diabetes Resource Center of Atlanta, Atlanta Diabetes Associates. “The new pump system is so smart it recommends the proper insulin dosage to the patient, after considering a number of variables, such as the amount of insulin previously delivered and still active in the body. The system simplifies this critical information process, so patients no longer feel as though they need to be mathematicians in order to keep their blood sugar levels in control."


More than 1 million Americans with Type 1 diabetes and another 3 million Type 2 diabetes patients are estimated to use insulin to control blood sugar levels, improve their health and attain a better quality of life. High and low blood sugar fluctuations can cause loss of consciousness or even death, as well as long-term complications, such as blindness, kidney failure, amputation, impotence and heart disease. For many patients, managing diabetes is difficult without frequent blood glucose monitoring and the use of an insulin pump.


“This new system represents a significant advancement in managing diabetes. We have known for some time that an insulin pump can more closely mimic a healthy pancreas. Now we have harnessed the full potential of the pump with our patented Bolus Wizard calculator to simplify and enhance dosing decisions for anyone who uses insulin to manage their diabetes,” said Jeffery A. McCaulley, vice president and general manager of Medtronic MiniMed. “This dosing support and integration of the blood glucose meter have the potential to attract a much broader complement of patients and physicians to pump therapy.”


“The power of glucose monitoring and the benefits of insulin pump therapy are now combined in a patient-friendly system that can simplify and improve diabetes management,” said Kevin Seifert, president, BD Consumer Healthcare. “BD’s alliance with Medtronic MiniMed allows us to combine our expertise, intellectual property and best-in-class technologies to bring a series of innovative products to market, further improving the lives of people with diabetes.”


The System


The Paradigm 512 Insulin Pump, which is the next generation Paradigm pump, features enhanced quality components and automatically receives a blood glucose value from the Paradigm Link monitor via wireless communication. The pump’s Bolus Wizard calculator recommends insulin dosage based upon preset information entered by the user (target blood glucose, insulin sensitivity and insulin-to-carbohydrate ratios). The pump’s calculator tracks the time and amount of insulin delivered by the patient and makes a dosing recommendation after subtracting the amount of insulin still remaining in the body. The calculator recommends an insulin dosage based upon a blood glucose reading, carbohydrate entry, or both. Prior to this integrated system, many diabetes patients mentally calculated the amount of insulin needed, a complex process that can result in dosing inaccuracies and lead to less than optimal blood sugar control.


The Paradigm Link Blood Glucose Monitor provides accurate glucose results in five seconds, uses the thinnest lancet on the market and requires one of the smallest test strip blood volumes (0.3 microliters). In addition to automatically transmitting a glucose value to the Paradigm 512 pump, the Paradigm Link monitor also serves as an information “conduit” for patients who wish to download, store and review historical information from their Paradigm insulin pump to a personal computer.


Paradigm Pathway Program
As Medtronic MiniMed continues to develop new features for its 500 series Paradigm pumps, users can purchase upgrades during their warranty period, in order to stay current with the latest technology advancements. The first Paradigm Pathway Program offering enables Paradigm pump users to purchase an upgrade and receive the Paradigm 512 and Paradigm Link monitor system. This pathway program is available to owners of Paradigm 511 pumps.


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