Insulet Enrolls First Patients in Clinical Trial for its Omnipod® Artificial Pancreas System

Diabetes Technology
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From Seeking Alpha

Study Brings Insulet Another Step Closer to Providing its Omnipod® Horizon™ Hybrid Closed Loop System to People with Diabetes

BILLERICA, Mass.–(BUSINESS WIRE)-- Insulet Corporation (PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced the first patient has completed the feasibility study of the Omnipod Horizon™ Automated Glucose Control System (Omnipod Horizon System). The full study will evaluate the use of a personal Model Predictive Control algorithm with the Omnipod platform in 20 adults with type 1 diabetes and is taking place in a clinical research center setting to gather data to be used to evolve the algorithm in subsequent studies leading to FDA submission.

“We are very excited to be participating in Insulet’s artificial pancreas clinical trials,” said Jordan Pinsker, M.D., senior research physician at William Sansum Diabetes Center. “Working with Professor Francis J. Doyle III and Dr. Eyal Dassau, Sansum played a major role in the development of the original UC Santa Barbara Artificial Pancreas algorithm that Insulet acquired. We look forward to contributing to the clinical and development pathway as Insulet takes this promising technology to a commercial product.”

The Omnipod Horizon System will combine best-in-class technologies into one integrated system consisting of an on-body Omnipod tubeless pump, the latest Dexcom continuous glucose monitoring (CGM) technology, a modified version of Insulet’s handheld controller and state-of-the-art security system architecture. Insulet’s Omnipod Horizon System is unique in that the algorithm looks toward the future horizon of blood glucose levels, reacting quickly and efficiently to adjust insulin delivery to optimize outcomes for each user. The system will provide the same proven lifestyle benefits as the current Omnipod System, such as the discreet, reliable, tubeless form factor and up to three days of non-stop insulin delivery to make it easy to stay connected and avoid disruption of insulin delivery during routine activities like exercising and bathing.

Full announcement here

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A commercially available Arificial Pancreas System would definitely get me to use a pump. Looks like study will be complete in December 2016 so maybe there is hope for this in the next year or so.

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There are other exciting efforts as well. Here are a couple off the top of my head:

Bigfoot

iLet

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I went out to the BigFoot website and learned more about how the company started. There is some good audio content there, including Diabetes-Connections. Diabetes is an indiscriminate disease. In this case diabetes touched on some talented and smart parents that are making a good effect. BigFoot was started by four diabetes dads. Inspiring.

Clinical trials are on now and they are currently recruiting for Santa Barbara and Stanford. Check out clinicaltrials.gov and search on “bigfoot.”

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I’m really hoping the Joslin and my endo will be involved in testing out the Omnipod Horizon system. I’m not interested in tubing and I’m already familiar with both the main components of the system so I will not be starting at ground zero. My friend is patient 005 in the trial in California so I’m anxious to read her report.

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You better look at the cost as well. This will not be covered by insurance if the are too expensive

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I was quite skeptic to all this closed loop talk until I tested the RileyLink + Loop kit that few geniuses created. Now an app on my iPhone is collecting data from Dex G5 and instructing the pump (MM523) what to do. The results so far are way over my expectations. Of course, nothing is clinically tested, but it works!

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I have a friend in the trail in CA too. I’ll have to ask her number. Would be funny is it was the same person!

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I believe the major players in AP projects are very cognizant of the need to have insurance coverage in order for their product launch to be successful, and are working with insurance companies to ensure that there will be coverage.