BBI

Smaller, lighter, niftier and easier to use while still containing both more features and more advan-ced features. These are some of the key characteristics of new devices being developed to make the management of diabetes more effective by being more "patient-friendly." Two firms Animas (West Chester, Pennsylvania) and Insulet (Bedford, Massachusetts) offered the most recent examples with recent product rollouts.

Insulin manufacturer Animas launched its newest pump, the Animas IR 1250, last month, providing two new features to upgrade its previous 1250 model that will offer critical carbohydrate information and another to allow users to make a bit of a fashion statement.

The company said the IR 1250 is "another step toward Animas' quest to make diabetes management easier." Intensive management of diabetes requires that people with diabetes administer insulin to compensate for carbohydrates ingested, the company said, and Animas is trying to make those carbohydrates easier to count.

Specifically, the product incorporates a food database of up to 500 items to make carbohydrate counting particularly important for patients with diabetes easier. Also, the pump offers tunes instead of beeps when it is time for the patient to bolus, or inject insulin.

"Among the small differences, it has a food database that can be downloaded via Calorie King, which is the most widely accepted book on carb counting and calories and fat," Audrey Finkelstein, executive vice president of Animas, told The BBI Newsletter. "It can download 500 items, so instead of having to carry that book around with them, they have it just at the touch of a button."

Those 500 items are pre-loaded into the pump by Animas because some people are not techno-friendly. But for those who want to take fully advantage of this feature, a patient can download as many as they like, although Finkelstein said, "most people eat around 50 different foods." And those entries can be customized for each patient.

"If you know that every time you go to your favorite pizzeria, and you figure out how many carbs there are in a slice of pizza there, you don't have to remember, you can add it in," she said. Another reason customization is important, Finkelstein said, is that "so much in carb-counting is trial and error."

Not only does the pump provide a database for research carb counts, which can be done while eating, it also can add the carbohydrates in up to nine items in a meal. The device automatically calculates the number of carbs and the insulin ratio, which instructs the patient on how much to bolus, completing all of the calculations for the patient.

Animas said the IR 1250 "follows in the footsteps of earlier generations of Animas pumps with its waterproof integrity, ease of use, long battery life and advanced features for more precise insulin delivery." But it also offers another feature that is alarms that sound as a choice of tunes rather than beeps.

CEO Katherine Crothall said, "Many people, particularly teenagers, wish to be discreet with their diabetes, and using tunes in lieu of beeps help[s] them achieve this goal. Our IR1250 pump not only looks like a small cellphone, but it now sounds like one as well."

As Finkelstein pointed out, the last thing any teenager wants is to be seen as different. So if a beep goes off in a classroom or the movies or another social situation, they may have to explain to those around them what the beeps are. With tunes, it will sound just like a cellphone. There are also stickers to put on the phone.

"There are very few choices that you have when you have diabetes," Finkelstein said. "So, the things that you can choose are the colors that you can make the pump or the different stickers that you could put on."

One thing that she never expected, she said, was to see middle-aged men and women also making the same fashionable choices for their pump.

The IR1250 model pump will cost the same as the IR 1200 pump, or about $5,000. There won't really be any difference in the way they market the device.

And it won't be the last pump that Animas develops.

"We continue to strive for greater advancements in diabetes management as reflected in our recent acquisition of our MicroPump and MicroNeedle technology from Debiotech [Lausanne, Switzerland]." Crothall said. "Our significant progress in developing a more accurate glucose sensor, our continued advancements in insulin pump development and our micro technology take us yet another step closer toward a viable closed-loop system."

For its part, Insulet has accomplished precisely what it set out to do for diabetes patients. President and CEO Duane DeSisto told BBI 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 Insulet'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). Insulet 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, it said, the PDM, which DeSisto said "basically relies on FreeStyle meter technology [from TheraSense (Alameda, California)]," is used to check blood glucose levels, give bolus dosages and adjust basal rates.

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 BBI.

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 insulin 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.

On the diabetes testing side, Biomerica (Newport Beach, California) said last month that it has added a new diabetes test to its arsenal of diagnostic tests for labs to evaluate patients for the chronic disease, one that many experts say the rates of which are increasing at the speed of an epidemic. The new blood test will measure levels of C-peptide. The company said that C-peptide levels in blood are about five to six times greater than insulin levels and are more stable.

According to the American Diabetes Association (ADA; Alexandria, Virginia) C-peptide is a "connecting peptide," or a substance the pancreas releases into the bloodstream in equal amounts to insulin. The ADA said that measuring the level of C-peptide "shows how much insulin the body is making.

While other companies, notably Abbott Diagnostics (Abbott Park, Illinois), offer C-peptide tests, Biomercia did not until now. However, the company does offer an islet cell autoantibody test (Isletest-ICA), insulin autoantibody test (Isletest-IAA) and GAD Autoantibody (Isletest-GAD). "The C-peptide [test] is more of today's problem [with diabetes]; the other three we have are more [for] problems down the road," Biomerica President Fran Capitanio told BBI.

The C-peptide test is designed to allow clinicians to differentiate between Type 1 and Type 2 diabetes. It also is used to indicate the need for a patient to progress to insulin therapy in Type 2 diabetes. It's essentially intended for patients who already have been diagnosed with diabetes to monitor their condition on an ongoing basis, Capitanio said.

C-peptide also is used to determine the cause of hypoglycemia, or low blood sugar, and to monitor the recovery of a patient after the removal of an insulin-producing tumor of the pancreas, the company said. Also, it noted a recent study published in the Journal of the National Cancer Institute that linked elevated levels of C-peptide with an increased risk of colorectal cancer in men with diabetes.

"Our new C-peptide test is a substantial product addition to our current diabetic line of tests which help detect the onset of diabetes," Biomerica CEO Zackary Irani said in a statement. "The introduction of this product to our already existing customer base should not only result in increased sales, but should enhance Biomerica's presence in the clinical laboratory diabetes market."

The test is meant for patients to have at a clinical lab, Capitanio said, rather than in a physician's office. He said that having the C-peptide test would allow Biomerica to become more competitive by offering the test to laboratories. Because the test is not a new test, it will be covered by insurers.

"We can [now] say that we've got more of a package of diabetes tests than just an individual test," Capitanio said. And he said that kind of "package" is exactly what laboratories are looking for.

With the well-publicized growing epidemic of obesity and diabetes in the U.S and elsewhere, the demand for such tests is only expected to increase. "Biomerica is focusing on diabetes as one of its areas of focus, so we will have other tests coming down the road, and this is just part of that," Capitanio said.

Biomerica also offers rapid visual tests that can be used at home or in the physician's office. Among those are EZ Detect Fecal Occult Blood Test, EZ-PSA One-step PSA (prostate-specific antigen) test and EZ-HP One-Step H. pylori Test, as well as ovulation tests and pregnancy tests. The company's clinical laboratory tests include those for thyroid testing, ulcer testing, calcium metabolism testing, anemia products tests for allergies and pituitary testing.