Insulet (Bedford, Massachusetts) has accomplished precisely what it set out to do for diabetes patients.

President and CEO Duane DeSisto told Diagnostics & Imaging Week that in 2000, the company, which today has grown to 77 employees, "was formed with the concept of coming up with a fully programmable, full-featured disposable insulin pump."

Earlier this year, the FDA gave 510(k) clearance to Insu-let's OmniPod Insulin Management System, a two-part system that the company said combines the "proven healthcare benefits of continuous subcutaneous insulin delivery and blood glucose monitoring."

"To make a long story short, we've raised $70 million to date . . . we have FDA approval of a product that is commercially viable, and we're sort of excited to get going in the back half of the year," DeSisto said.

The device's two components are the OmniPod and the Personal Diabetes Manager (PDM). The company said the OmniPod is a "small, lightweight device that combines an integrated infusion set, automatic inserter and insulin reservoir.

"The pod is worn discreetly and comfortably on the skin beneath the clothing and delivers insulin according to pre-programmed instructions from the wireless, handheld PDM," Insulet said.

Once the OmniPod is programmed, the company said, the PDM is used to check blood glucose levels, give bolus dosages and adjust basal rates. Desisto said the PDM "basically relies on FreeStyle meter technology [from Therasense (Alameda, California)]."

The device also allows user interaction, such as entering food information when they're about to eat certain food, and then allows the user to test his or her blood glucose. The bolus estimators would calculate that, based on their knowledge of what is being eaten, and would recommend a certain bolus. The patient can then agree or disagree and then signal the device to bolus by pushing a button.

While the glucose meter is from TheraSense, the technology allowing the patient to interact with the device is Insulet's.

The OmniPod component is worn for up to three days directly on the skin, which must be sterilized before the adhesive is attached. It must be filled with insulin before being attached. Once the second part of the device triggers it to do so, the OmniPod "fires" a cannula with a Teflon coating into the body under the skin before retracting immediately, leaving a Teflon cannula to administer the insulin.

"You never see a sharp [and] there are no separate insertion devices," DeSisto said. "It all happens automatically, so someone who is needle-phobic will never even see the needle."

He noted that most existing insulin pumps require 24 to 40 inches of tubing, an insertion device or a prime, but that OmniPod does not. Since there is no tubing connecting the OmniPod and the PDM, the PDM can be carried separately in a briefcase or purse when the patient is not using it manage their insulin or check their glucose.

Other features of the OmniPod Insulin Management System are a "user-friendly, intuitive" user interface, the ability to store and review insulin delivery, carbohydrate and blood glucose results and a built-in food reference library for calorie and carb-counting.

"Our goal has always been to improve quality of life for people with diabetes by simplifying management and addressing the concerns of individuals who live with diabetes every day," DeSisto said in a statement. "The new OmniPod Insulin Management System offers a safe, convenient and discreet solution for patients that want to take advantage of the many benefits of intensive insulin therapy without the hassle of injections and the complexity of conventional insulin pumps."

While the OmniPod eliminates the need for injecting oneself with insulin, the device is not completely without pain, although it is much less pain than is felt with existing technology, he said.

This is not the first time that Insulet has been down this road. Last year, the company received FDA clearance for a prototype device, but that version was not manufacturable. Unlike that prototype, the newer version "should lend itself to high-speed automation," DeSisto said. The original version also did not have a glucose meter, while the new one does.

"We feel comfortable about what we have [now]," DeSisto told D&IW.

The device will rely on existing reimbursement codes for current insulin pumps. As for the price of the device, DeSisto said, "We're still kicking that around."

"What I can tell you is today's existing inulin pumps [run] anywhere from $3,500 to $6,500. This will be just a fraction of that. Our strategy is pretty much for the insurance carriers as well as the patients to [incorporate] the pay-as-you-go model," he said.

The company will be adding marketing and sales staff when the time comes to bring the product to market. Initially, the target of their efforts will be endocrinologists.

While vendors will be producing some of the parts, Insulet will do the final manufacturing of the device.

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