Monday, May 6, 2013
Insulet
Medical Device Daily™
Continued from Page 1 ‘how do you use U-500 in the pump and how do you dose it and is it safe to do?’ And the problem with answering that question is that it has not been approved for use in a pump, but everybody’s using it off label.” Bode is a diabetes specialist with Atlanta Diabetes Associates and is a clinical associate professor in the Department of Medicine at Emory University (Atlanta). And because one unit of U-500 is as powerful as five units of U-100, both doctors and patients have to be extra careful that they are giving the correct amount of U-500 whether they are putting it in a pump or a syringe. “So when people go to U-500 either in a syringe or in a pump, you have to do all of these calculations. One, you have to do it for the patient if you’re putting it in a pump, so you’re fudging everything by five times,” Bode told Medical Device Daily. “ . . . That can create a lot of errors.” To address this problem, Insulet (Bedford, Massachusetts), a company known for its tubeless insulin pump technology, has entered into an agreement with Eli Lilly to develop a new version of the OmniPod insulin pump specifically to deliver Humulin R U-500 insulin (Medical Device Daily, May, 3, 2013). This new version of the OmniPod System would be the first insulin pump designed with specific feature modifications to deliver Humulin R U-500 insulin. “This is a huge step forward . . . it will allow patients to give high-dose insulin in a safe and effective manner,” Bode said. “This will be very good for patients who are markedly insulin resistant and it will be very good for healthcare providers because they don’t have to be doing these calculations.” Insulet said it will partner with Eli Lilly on the clinical development program to evaluate the safety and efficacy of the combined delivery system. “We are pleased to develop the first insulin pump specifically for Humulin R U-500 insulin to bring the advantages of the OmniPod System to people with highly insulin resistant Type 2 diabetes,” said Duane DeSisto, president/CEO of Insulet. “The tubeless design of the OmniPod insulin pump provides freedom and ease of use for tens of thousands of people living with diabetes today.” Late last year, Insulet reported FDA 510(k) clearance for its second-generation OmniPod system (Medical Device Daily, Dec. 17, 2012). In a conversation with MDD following the FDA clearance, Insulet CFO Brian Roberts said the new OmniPod is the equivalent of the newest generation iPod compared to an old eight track cassette player or vinyl record player. The OmniPod system is the world’s first tubeless insulin pump. It consists of a Pod, which automatically inserts and can be worn on many parts of the body to hold and deliver insulin, and a hand-held device that wirelessly programs the Pod, calculates suggested doses and has a built-in blood
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glucose meter. Importantly, the system is also tubeless and waterproof, Roberts noted. The company introduced the first generation of the device in 2005. Humulin R U-500 is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with Type 1 and Type 2 diabetes mellitus. “I think this is going in the right direction to make insulin safer and U-500 is not as safe in ordinary practice because you have to do these reverse calculations and people can make very dangerous mistakes,” Bode said. “The FDA has stated that they will not approve any new concentrated insulin that is coming out unless it’s in a dedicated delivery device.” Other options for insulin-resistant diabetes patients, other than the U-500 insulin, include bariatric surgery and GLP-1 (glucagon-like peptide 1) drugs, or a low-calorie diet, which is defined as less than 800 calories a day. The primary treatment option for this patient population, Bode said, is bariatric surgery but not everybody wants to undergo surgery and patients have to have a body mass index (BMI) greater than 35 (but, he noted, most surgeons prefer the patient have a BMI greater than 40). As for the other non-insulin treatment options, Bode said compliance is a problem with both the low-calorie diet and the GLP-1 drugs. n Amanda Pedersen, 912-660-2282; amanda.pedersen@ahcmedia.com
Financings
Continued from Page 2 to a national securities exchange. The company is also terminating its previously reported offer to exchange with respect to the investor warrants only. • DocuTAP (Sioux Falls, South Dakota) said that has raised $1 1 .9 million from Bessemer Venture Partners to make sure that if something does go wrong, it is not the result of disorganization. DocuTAP helps urgent care clinics digitalize their operations to make them more efficient and less reliant on paper. The software integrates electronic health records and “practice management” technology so all the information and tools needed to operate an efficient practice is one place. The platform is accessible on tablets so clinicians can use it on-the-go. DocuTAP also features automated and customizable tools so each clinic can tailor the software to their needs as well as billing services.
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