The Project: Create an insulin pump alternative that is discrete and easy-to-use.

The Solution: Use RF technology and an MCU in the manufacture of a small, wireless diabetes treatment device.

By Luis Malavé
Until recently, the only insulin treatment options available for the more than 18 million Americans and 194 million people worldwide estimated to have diabetes consisted of multiple daily insulin injections or a conventional insulin pump. As this life-threatening, chronic disease continues to grow at alarming rates (with an increase of 50% over the last decade), better treatment alternatives are needed to assist people in managing their diabetes.

The OmniPod
Insulin Management System
Continuous subcutaneous intensive insulin therapy is intensive diabetes management with the goal of achieving near-normal levels of blood glucose and improved lifestyle flexibility. Traditionally available only with insulin pumps, this has long been recognized as the most effective form of diabetes management and has been shown to reduce the long-term complications of diabetes. However, the obstacles to adoption of conventional insulin pumps–lack of discretion due to the tubing, the need to learn complex technology, and cost–have limited insulin pump use among people with diabetes. Currently in the U.S., only about 5% of insulin-requiring diabetes patients use insulin pumps.

To overcome these obstacles, Insulet Corp. was founded in 2000 to design and develop alternative options that address the concerns and simplify treatment management for individuals who live with diabetes every day. After extensive research regarding the needs of patients and utilizing the latest radio frequency (RF) and microcontroller (MCU) technology from Freescale Semiconductor, Insulet developed the OmniPod Insulin Management System. The OmniPod is an insulin delivery system featuring two, fully integrated wireless components–the OmniPod and the Personal Diabetes Manager (PDM).

The OmniPod System was developed to be easy-to-use, discrete, and affordable. The system eliminates the need for daily insulin injections and doesn’t require the patient to be tethered to a conventional insulin pump via tubing. Designed to help overcome common concerns about conventional insulin pump therapy, the OmniPod eliminates the complex technology, conspicuous tubing, and cumbersome components of conventional insulin pump systems. It became available, with a prescription, in late 2005.

“The OmniPod System gives people with diabetes access to the best possible therapy, with increased lifestyle flexibility and at a price that makes sense,” said Rob Campbell, manager of technology and innovation at Insulet and an OmniPod user. “This system allows diabetes educators and physicians to focus on the true need, which is assisting the patient with diabetes without worrying about the technology.”

The OmniPod is a small, lightweight, self-adhesive pod that delivers insulin, according to a person’s pre-programmed personal basal rates and bolus dosages. The Pod also features an automated cannula insertion process that was designed to reduce insertion errors and increase the consistency and comfort of cannula placement. Automating the insertion process may also reduce the anxiety and pain associated with traditional daily insulin injections or the insertion of infusion sets associated with conventional insulin pumps. Additionally, the Pod is small and can be discreetly worn under clothing where conventional pumps have tubing attached to a pager-like device that is not easy to conceal. The user changes the Pod about every three days.

The PDM–the wireless, intuitive, hand-held device that programs the OmniPod with customized insulin delivery instructions and monitors the OmniPod’s operation–contains a fully integrated Freestyle Flash blood glucose meter and automatically stores patient records.

To meet the price and performance requirements of this system, Insulet looked to Freescale Semiconductor to develop a combination of standard MCUs with custom RF silicon. “No one else could match both the RF technology at the required price points,” said Luis Malavé, senior vice president of research, development, and engineering at Insulet. “Additionally, Freescale is one of the few companies that had the technology to make these devices into a single package solution.”

The OmniPod uses the MC9S08RX32A which has two die inside a single package–a custom RF integrated circuit (IC) and a standard MC9S08GB60A 8-bit MCU. The PDM uses the Freescale Dragonball microprocessor, the brains of the wireless device, as well as the same MC9S08RX32A, enabling a true wireless connection.

The MCUs manage the flow of insulin as well as the MCU and RF IC interface with the handheld controller (the PDM) to relay information, manage, and monitor the flow of insulin. Additionally, the devices offer safety features built into the software.The custom silicon from Freescale helped simplify the operation of the pump, making it easier to use. To meet the cost-, space- and power-savings, it was important for Freescale to reduce the size and cost of the RF IC and MCUs into a single package.

“This was truly a global effort on Freescale’s part in that countless worldwide calls took place to help Insulet make the combination of the RF ICs and MCUs work in the system,” said Gary Sawyer, account manager for Freescale Semiconductor. “Freescale was in a unique position to work with Insulet in that no one else offers the complete solution and Insulet also benefited from the cost and resource savings of having a single source of supply for the RF devices and MCUs.”

Insulet’s system is designed to make diabetes a smaller part of life for people with insulin requiring diabetes by providing more freedom, convenience, and peace of mind. “We have a huge opportunity to change the therapy for the Type 1 diabetes marketplace,” said Jeff Smith, vice president of marketing and business development at Insulet. “There are currently more than 1.3 million people in the U.S. alone with Type 1 diabetes and only 280,000 of them use conventional insulin pumps. As we have developed a cost-effective system that is easy-to-use and discrete, we expect the number of people who switch from syringes and conventional insulin pump therapy to ramp up tremendously over the next few years, significantly changing the face of treatment options for people with diabetes.”
For additional information on the technologies and products discussed in this article, see the following websites:

Luis Malavé is the senior vice president of research, development, and engineering at Insulet Corp., 9 Oak Park Dr., Bedford, MA 01730. He has over 20 years of experience in the medical device industry, including 15 years of experience in insulin pump development. Prior to joining Insulet, he served as the director of research and development for Medtronic MiniMed’s External Products division, where he managed the development of several of their insulin infusion pumps. Malavé can be reached at 781-457-5000 or