FDA Approves First Artificial Pancreas Faster Than Anyone Expected

By Dan Hurley | October 10, 2016 1:37 pm
28june2016-hybridclosedloopsystem2

The MiniMed 670G hybrid closed-loop system. (Credit: Medtronic)

“My guess is that even Medtronic is surprised.”

So said Jeffrey Brewer, the visionary tech entrepreneur who has been leading efforts to bring an artificial pancreas to market for a decade, in response to the unexpected news on Sept. 28 that the Food and Drug Administration approved one developed by Medtronic, already a leading manufacturer of insulin pumps.

A mere two weeks earlier, results were released of the largest and longest study yet of the device that fuses two existing technologies — an insulin pump and a continuous glucose monitor that measures blood-sugar levels 24/7 — together with a computer algorithm that permits automatic delivery of insulin for people with type 1 diabetes.

The most severe form of the disease, type 1 diabetes is diagnosed when a person’s biological pancreas stops producing nearly all insulin. As described in Discover in an article published just five months ago, the artificial pancreas is as small as a cell phone and worn externally, with thin tubing inserted beneath the skin and changed out every few days.

The new study found that Medtronic’s device kept people with type 1 within their desired blood-sugar range 72 percent of the time, compared to 67 percent of the time when controlling their own insulin dosing. That may not seem like much, but it comes without the person having to fuss over how much insulin to take, a huge benefit when dealing with a lifelong illness.

Strong Results

Convinced by the study results, the FDA approved Medtronic’s device, called the MiniMed 670G hybrid closed-loop system, for people with type 1 diabetes who are 14 years of age and older. It ordered the company to conduct continuing studies of the device once it goes on sale.

As the “hybrid” part of the name implies, the device is not fully automatic. Diabetics will still have to type in the amount of carbohydrates they’re eating at every meal. The device will then calculate and deliver how much insulin it thinks is necessary based on the person’s current blood-sugar level and prior history of responses.

So quickly did the FDA approve Medtronic’s application that the company said it will not begin selling it until the spring of 2017, to permit manufacturing readiness, coverage by at least some health insurers and training of its employees, who in turn will have to train doctors and patients in how to use the device.

Getting It All Started

Brewer kick-started the drive toward bringing an artificial pancreas to market 10 years ago, when his son was diagnosed with type 1 diabetes. Flush with cash from the sale of an online company he’d started, Brewer made an audacious offer to JDRF, the non-profit group (formerly known as the Juvenile Diabetes Research Foundation) that funds research toward curing type 1: Begin focusing on the artificial pancreas, and he would donate $1 million.

Not only did JDRF say yes, but it soon appointed Brewer its president. Under his leadership, JDRF convinced manufacturers, academics and the FDA to stop dithering (the systems that had been under plodding development since the 1970s) and get serious about putting one in the hands of diabetics.

After the FDA established what it called a “road map” toward getting a device approved, Brewer left JDRF two years ago to start an artificial pancreas company of his own. Together with Bryan Mazlish, a programmer whose previous gig was designing computer algorithms to buy and sell stocks, and Lane Desborough, who was then Medtronic’s chief engineer for diabetes, they formed Bigfoot Biomedical.

“Medtronic’s approval is very good news for us,” Brewer told Discover. “It shows that the FDA understands the need for these devices and isn’t going to delay their approval.”

The Best is Yet to Come?

He adds, however, that in his view, the Medtronic device is not what people with type 1 diabetes really need.

“It’s the old-school approach of having to count your carbs and enter them into your device,” he said. “And you don’t actually start on closed-loop therapy. You start off like with current technology, calculating everything yourself, and then your endocrinologist trains you on how to use it on automatic.”

The Bigfoot device, by contrast, requires meal alert but no carb counting, and no initial run-in phase. With over $30 million in funding so far, the company is now in the midst of its first, preliminary clinical trial, and plans to launch a trial large enough to win FDA approval next summer. If all goes according to plan, Bigfoot’s device would be on sale by 2018.

bigfoot-system

The Bigfoot Biomedical artificial pancreas uses a smartphone, insulin pump and data transmitter. All are connected through Bluetooth. (Credit: Bigfoot Biomedical)

Ed Damiano, the Boston University professor of biomedical engineering whose years of research into an artificial pancreas led him to start a company called Beta Bionics last year, said he also welcomes the news of Medtronic’s approval. Like Brewer, however, he also has his own views on how the best device should function.

Damiano’s device, the iLet, is designed to pump not only insulin, but also the hormone glucagon, normally released by the liver when blood-sugar levels go too low.

“Glucagon is a freight train that’s coming,” he said. “The insulin-only devices are great. They’re a huge step forward. But the addition of glucagon makes all the difference.”

So far, Beta Bionics has raised $1 million through crowd funding from hundreds of individual donors and $5 million from pharmaceutical giant Eli Lilly and Company. It has also applied for a $15.5 million grant from NIH to run the large clinical trial aimed at gaining FDA approval.

beta-bionics

The iLet device. (Credit: Beta Bionics)

At the University of Virginia, meanwhile, Boris Kovatchev, professor and director of the Center for Diabetes Technology, received a $12.7 million grant from NIH to lead an international trial of yet another artificial pancreas system.

The study involves nine universities, including the Joslin Diabetes Center, Harvard, the Mayo Clinic and Stanford. The trial, starting this fall, will be longer and larger than any other, involving 240 people with type 1, each of whom will wear the device for six months. The resulting device will be marketed by a company named Type Zero.

For his part, Brewer says he is not disappointed by the progress of his competitors.

“I never thought it was a race,” he said. “We’re focused on getting it right.”

As the first to cross the finish line in this non-race, then, Medtronic has plenty of company as it seeks to make life for people with type 1 diabetes safer and easier.

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  • http://www.mazepath.com/uncleal/qz4.htm Uncle Al

    Having human-implantables interfaced with the FDA in the 1980s, my singular personal curiosity would be which FDA poobahs suddenly drive nicer cars. End of year is the time to grab wonderful bargains on remaining stock – both ways.

  • darryl

    Not exactly an artificial pancreas, since it only deals with insulin and not other enzymes, but very important nevertheless.

    -d

  • Brandi

    Good FDA. In July of 2015. it was discovered that I got type 2 diabetes, By the end of the July month. I was given a prescription for the Metformin, I stated with the ADA diet and followed it completely for several weeks but was unable to get my blood sugar below 140, Without results to how for my hard work. I really panicked and called my doctor. His response?? Deal with it yourself, I started to feel that something wasn’t right and do my own research, Then I found Lisa’s great blog (google ” HOW I FREED MYSELF FROM THE DIABETES ” ) .. I read it from cover to cover and I started with the diet and by the next morning. my blood sugar was 100, Since then. I get a fasting reading between the mid 70s and 80s, My doctor was very surprised at the results that. the next week. he took me off the Metformin drug, I lost 30 pounds in my first month and lost more than 6 inches off my waist and I’m able to work out twice a day while still having lots of energy. The truth is that we can get off the drugs and help myself by trying natural methods..

    • Nathan

      Congratulations for succeeding with natural methods, but you have Type 2. Type 1’s like me don’t have that option.

  • disqus_t0RkOnWGvs

    I’m not impressed…. I’ve had type 1 for 25 years. Here are my issues with it/criticisms….. glean what you will from them:

    “The new study found that Medtronic’s device kept people with type 1 within their desired blood-sugar range 72 percent of the time, compared to 67 percent of the time when controlling their own insulin dosing. That may not seem like much, but it comes without the person having to fuss over how much insulin to take, a huge benefit when dealing with a lifelong illness.”

    It had such potential… then they went and messed it up by having such a terrible success rating. It could likely be improved by eating low carb, but still…. if it thinks your blood sugar isn’t high at 150, it’s probably not giving insulin, and 150 is way too high. Normal blood glucose is 83 mg/dL. I achieve this much of the time (A1C 4.9) with MDI. If it’s not getting near my MDI control, why would I switch?

    This bit is also dangerous:
    “As the “hybrid” part of the name implies, the device is not fully automatic. Diabetics will still have to type in the amount of carbohydrates they’re eating at every meal. The device will then calculate and deliver how much insulin it thinks is necessary based on the person’s current blood-sugar level and prior history of responses.”

    Carbs aren’t the only thing that raise blood sugar. Protein also does. Frustrating that people designing the technology don’t understand how type 1 works, especially if the head researcher’s son has diabetes. Protein affects your blood sugar about half as much as carbs.

  • Stacy Smith

    I would like my son to take part in the trial study for the 6 month duration. How do you apply for a spot?
    garfieldspiritwear@outlook.com
    Thank you!

  • Cynthia J Loman

    I myself have a Type 1 diagnosed at 12 and is now 18 and in first year of college. It has been a struggle since diagnosis and the I forgot seems to be a regular thing for us . He is currently on a omni pod pump but have to wonder if this system would not be better at helping him be as close to a normal kids as possible. He hates his disease and the restrictions it places on his life. I do wonder when it becomes available for purchase what is the pricing we are looking at as I figuire most insurance won’t cover or even assist in paying for it?

    • Mary Ellen

      I have AETNA PPO and they pay for the medtronic pump with the GCM and I think most companies will pay for this eventually. I however did not have good luck with the GCM part of it at all. There was always a wide gap for me between what the GCM said my capillary blood sugar was and my finger stick glucose. I know this kind of system works for many people, but it didn’t for me. I would be hesitant to use a system that might automatically start injecting insulin. I would have to read the statistics of how many people it works for and what their body composition (fat, skinny, normal weight) was an how effective it was for each group. Not sure they have done any studies comparing the usefulness among body types. I was fat and would get alarms saying my blood sugar was high and my finger stick would say it was 60 and sometimes I would get a low alarm and my BS would be in the 120’s. I finally gave up and just test my BS frequently

  • Stook

    The latest development in technology leads for the better performances. The demand for the much better performance sight begins by using the specified formulation. The working leads for better results.

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