Even though Ed Damiano isn't living with diabetes, he occasionally wears a continuous glucose monitor and two 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 colored water, with blue liquid representing insulin and red standing in for fast-acting glucagon. The is wearing the devices in the name of his 13-year old son, David, diagnosed with type 1 more than a dozen years ago. But he's also in it for the bigger diabetes community, as the diabetes devices represent the future of Damiano's work on a "bionic" artificial pancreas that's now moving into the key research period from clinical settings to the real world.
We first chatted with Damiano in 2011 about his human clinical trial work that's a joint effort between researchers at Boston University, Harvard Medical School and Massachusetts General Hospital. The initiative is just one of across the U.S. and abroad developing and studying artificial pancreas models, and as with many involved in this kind of research, it's personal for Damiano.
He stepped into the diabetes community about 12 years ago when his wife Toby, a pediatrician, diagnosed their son at 11 months. They had no family history and didn't know anything about the autoimmune condition, but quickly learned what they needed to do for their son. With an academic background in mechanical and biomedical engineering, Damiano put his experience to use at the University of Illinois and started pondering ways to come up with a technological method to automate what D-parents and PWDs must currently do manually to control blood sugar levels.
The CGM component is a special custom-designed device by Tandem that merges an Abbott Freestyle Navigator receiver (a now-defunct device in the U.S.) and an off-the-shelf iPhone 4 (!), enclosed together in a black plastic shell. The combo device is about as thick as three iPhones, with a screen on both the front and back sides. It even has a slot to carry test strips! A special app calculates the algorithm and communicates wirelessly to the insulin pumps, and then also sends everything to the "iCloud," where all the data can be accessed and managed. Not to worry: for this round of experiments, the cellular and texting function is turned off on the phone, so users only have access to the pancreas app and can't access other phone functions.
This current version will be used in upcoming studies, Damiano says, but his team is working with Dexcom to create an updated version that will be similar except that it will use the new Dexcom Gen4 sensor, currently under regulatory review. He hopes the new model will be ready in a month or two, since rumor has it FDA will approve the new sensor by the end of 2012.
Following the ADA Scientific Sessions recently this past summer, where he and his team presented some research findings (and Damiano wore and demonstrated the system with colored water!), they received a grant for a new study using the glucagon-filled pump — a component that makes their initiative unique among those studying the artificial pancreas concept. The idea , but it's become more feasible as glucagon has evolved and dual-chamber pumps have started being envisioned.
Damiano describes the dual-chamber pump using glucagon as being better protection against hypoglycemia than the Low-Glucose Suspend (LGS) function that's currently available in Europe but still being reviewed by FDA here in the U.S. The LGS function temporarily stops insulin delivery once a PWD reaches a programmed BG level, but Damiano says the function is too slow and someone could be hovering at dangerously low levels or even be continuously dropping as the LGS just starts to kick in. Instead, the glucagon-filled pump can respond quicker and start raising a person's BG levels by basically bolusing small amounts of the fast-acting glucagon immediately.
"It's proactive and much more effective than LGS. From a regulatory perspective, the insulin delivery doesn't change but this adds a safety net," he said. "The Achilles Heel is the danger that the sensor might not be accurate and (delivering glucagon) could push you up higher, and that really goes at the fact that the U.S. sensors we have right now aren't good enough. But that will come with time."
Damiano sees a lot of potential for a glucagon-only pump, which could be a "transitional device" that might get approved and become available for people who pump or inject insulin before any more complex artificial or bionic pancreas. A three-year study planned for sometime next year would potentially allow PWD study participants to wear the glucagon pump for 11 to 14 days, using their own insulin therapy during that time.
The next phase of bionic pancreas research will begin at the end of 2012, Damiano says. The overall timeline is quite ambitious: