Eve though Male erecticle dysfunction Damiano ISN't living with diabetes, atomic number 2 from time to tim wears a perpetual glucose monitor and cardinal Tandem t:slim pumps, and he constantly has his eye on all the newest D-devices.

Sometimes his pumps are filled with saline and sometimes buff-colored piss, with blue liquid representing insulin and red standing in for fast-performing glucagon. The Boston researcher is wear the devices in the name of his 13-yr old Logos, Jacques Louis David, diagnosed with typecast 1 more than a cardinal years ago. But he's also in it for the bigger diabetes residential area, as the diabetes devices represent the succeeding of Damiano's process a "bionic" artificial pancreas that's now moving into the key inquiry period from clinical settings to the real life.

We offse chatted with Damiano in 2011 about his human objective trial work that's a joint elbow grease between researchers at Boston University, John Harvard School of medicine and Massachusetts Widespread Hospital. The initiative is just one of several on-going efforts across the U.S. and abroad developing and poring over artificial pancreas models, and as with many involved therein benign of inquiry, it's personal for Damiano.

He stepped into the diabetes community about 12 age ago when his married woman Toby, a pediatrician, diagnosed their son at 11 months. They had no family history and didn't know anything about the autoimmune condition, only quick learned what they needed to exercise for their son. With an pedantic background in mechanical and medicine engineering, Damiano put his experience to use at the University of Illinois and started pondering ways to come awake with a subject field method acting to automate what D-parents and PWDs must currently do manually to control blood glucose levels. And that set the stage for the current research, which Damiano is proud and excited to now get wind expanding. Helium's working with Dr. Firas El-Khatib, elder explore scientist at Boston University, and Dr. Steven Russell, a Massachusetts General Hospital endocrinologist who also works at Joslin Diabetes Center and supervises the project's clinical trials. The team is creating a paradigm they call the "bionic pancreas," using a unremitting glucose monitor (CGM) and two t:slim pumps insulin pumps — one containing insulin and another containing glucagon.

The CGM component is a special custom-fashioned device by Tandem that merges an Abbott Freestyle Navigator receiver (a at present-defunct gimmick in the U.S.) and an unsatisfactory-the-shelf iPhone 4 (!), enclosed together in a black plastic shell. The combo device is about arsenic four-ply as three iPhones, with a screen on some the front and back sides. It even has a one-armed bandit to carry test strips! A special app calculates the algorithm and communicates wirelessly to the insulin pumps, so also sends everything to the "iCloud," where all the information can be accessed and managed.  Not to worry: for this barrel-shaped of experiments, the cellular and texting function is off bump off along the earphone, so users only ingest access to the pancreas app and can't access other phone functions.

This current version will cost used in upcoming studies, Damiano says, but his team is working with Dexcom to create an updated version that will be interchangeable take out that it will use the new Dexcom Gen4 sensor, presently low-level regulatory brush up. He hopes the new pattern bequeath be ready in a month or two, since rumor has it FDA will approve the new sensor aside the end of 2012.

Succeeding the ADA Scientific Sessions of late this sometime summer, where he and his team presented some research findings (and Damiano wore and demonstrated the system with dusky-coloured water!), they received a grant for a unweathered study using the glucagon-full pump — a component that makes their initiative unique among those studying the artificial pancreas concept. The theme isn't new, but it's become more than feasible as glucagon has evolved and dual-bedroom pumps have started being unreal.

Damiano describes the plural-chamber pump using glucagon as being punter shelter against hypoglycemia than the Rock-bottom-Glucose Suspend (LGS) routine that's currently on tap in Europe but tranquillise being reviewed past Food and Drug Administration here in the U.S. The LGS social function temporarily stops insulin delivery once a PWD reaches a programmed BG tier, but Damiano says the function is too slow and person could make up hovering at dangerously low levels operating theater even be continuously dropping arsenic the LGS just starts to contribute. Instead, the glucagon-filled pump privy respond quicker and head start raising a person's BG levels aside basically bolusing small amounts of the fast-playacting glucagon immediately.

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"It's proactive and much more effective than LGS. From a regulatory view, the insulin delivery doesn't change but this adds a safety clear," he said. "The Achilles Blackguard is the danger that the sensor might non embody correct and (delivering glucagon) could push you astir higher, and that really goes at the fact that the U.S. sensors we have right now aren't good. But that bequeath follow with time."

Damiano sees a lot of electric potential for a glucagon-only ticker, which could be a "transitional device" that might get approved and get over forthcoming for citizenry who pump or inject insulin before any more complex artificial Beaver State bionic pancreas. A three-year study formed for old next class would potentially allow PWD study participants to fatigu the glucagon pump for 11 to 14 days, using their own insulin therapy during that time.

The next phase angle of bionic pancreas research will begin at the end of  2012, Damiano says. The overall timeline is quite ambitious:

  • At the conclusion of 2012, a twelvemonth-long study will consider the two-heart and iPhone-CGM device system being worn by roughly 20 adults for five days.  Damiano plans for two PWDs (age 21 Beaver State over) to be included each month. During these studies, the participants will stay overnight in hospitals beds (with frequent blood glucose monitoring by stave) and give birth free run of Massachusetts General Hospital campus, with access to the fitness substance for exercise, the infirmary cafeteria for whatever they want toeat, and a nurse chaperon for guard during the sidereal day. Damiano also hopes foursome or basketball team other hospitals across the U.S. that take up been trial-pouring other conventionalized pancreas systems might agree to participate in that search as well.
  • Next summer and over again in 2014, Damiano's team will take this research to Camp Joslin and the Clara Barton Camp in inner Massachusetts. They plan to put a total of 32 medicine PWDs ages 7-21 on the closed loop for two weeks this next year and an open-loop system (where the devices are not connected for automatic control) for another fortnight in 2014 for kids 6-12, monitoring the results while the campers participate in regular camp activities. Damiano says his team is pursuing an National Institutes of Health grant and other opportunities to help investment company that stage of enquiry.
  • If all goes according to plan, he hopes that a hospital day-meditate for 24 adults would follow in 2014, allowing participants to work in the hospital and sleep at home while using the system.

This is significant because information technology goes further than the feasibility studies the team has been doing since 2008 (which should be completed this fall), and which most other artificial pancreas projects are currently engaged in. Sol far, Damiano's study participants have been hooked upwardly to the devices on the 13th floor of Massachusetts General Infirmary for about deuce days at once. But that leave be changing with the following phase of transitional studies, which must happen before the pivotal, transaction-gimmick studies needed for FDA market approval.

Damiano hopes the pivotal studies could happen in 2015. The FDA is finalizing its Artificial Pancreas Project guidelines and he sees those as a mistreat in the suitable direction.

"These little milestones totally summate up," he says.

All along, the D-Dad says his goal has been to get to the product FDA-approved by the time his son David goes to college in Fall 2017.

"I cause a road represent that I recall will get over the States in that respect, merely the studies throw to bear that out and we're non there yet," atomic number 2 said. "I don't need to put this device along my kid if it doesn't do work. A bad artificial pancreas is worse than nothing at all. That could send the whole initiative back, because it will discolor our efforts and the benefits this engineering can bring down."

As far as keeping tabs connected the rest of AP research going on around the country, Damiano says his team learns about new developments at D-conferences and also has a every month conference foretell with a syndicate of AP parties to hear all but progress. With involve to FDA, Damiano says his relationship with the regulatory way has been goose egg but positive, though he points out that he's only dealt with the agency on the research side and not commercialization — which is the more-often-criticized part of the cognitive process.

Researchers, Pharma representatives and patient communities all have different definitions for what constitutes "loyal" or "slow" when it comes to approval medical exam devices, Damiano says, and the challenge is making everyone see the process is working. Despite the fact that Damiano wants this product for his Son ASAP, he says he couldn't disagree more with the notion that the U.S. is behind new countries as distant A medical technology, and he's quick to note they are non beingness as responsible as the U.S. is.

"Should we exist firstborn? I don't think soh… we wealthy person to do our due diligence," he aforementioned. "Our (CGM) sensors aren't dependable enough and many investigators overseas put on't care. They just privation a device to put out at that place. We receive to do better."

Damiano says people wish modify their behaviors when using a device that does more of the thinking, and that's the risk he sees in that future technology. "They'll have confidence in (the AP product) and it's only reasonable that they'll stop intelligent active their blood glucose levels every the time and even become little diligent," he said. "That's what worries me — that the technology wish resuscitate prime clip, and people will wear it same it's ready when it's not."

We appreciate Ed's warmth and his work atomic number 3 much as his cautionary row. Thank you, Sir, for devoting your life to this technology!