SAN FRANCISCO — Progress toward the development of a closed-loop ”artificial pancreas” has hit a new milestone, improving blood glucose levels in adults and teenagers with type 1 diabetes for 5 days straight in real-world settings.
The findings, from 2 separate studies of 20 adults and 32 adolescents, respectively, were presented here at the American Diabetes Association (ADA) 2014 Scientific Sessionsby Steven J. Russell, MD, PhD, of the diabetes unit at Massachusetts General Hospital and Harvard Medical School, Boston. The study results were also simultaneously published in the New England Journal of Medicine.
The so-called ”bionic pancreas,” being developed collaboratively between the Harvard group and a team led by Ed Damiano, PhD, from the department of biomedical engineering at Boston University, Massachusetts, is wearable and automated and incorporates glucagon in addition to insulin. Some other investigational closed-loop systems use only insulin.
”It’s a big step forward, because it’s the first time we’ve taken the bihormonal bionic pancreas and brought it into a realistic situation where we don’t make any restrictions on subjects’ diet, activities, or their routine. It’s much more challenging than a hospital environment where we’ve tested the system before,” Dr. Russell told.
Stuart A. Weinzimer, MD, associate professor of pediatrics at Yale University, New Haven Connecticut, who has done extensive research in this area, added, ”We’ve been anxiously awaiting the results of this study. I think it’s very exciting. It was an incredibly ambitious project.”
But Dr. Weinzimer noted that the system remains imperfect, as patients still experienced some highs and lows requiring intervention. ”I think we’re never going to get rid of the human interaction with the system, at least until we have much faster insulins. There’s always a trade-off between control and involvement, and the artificial pancreas isn’t going to remove that completely.”
The ”bionic-pancreas” device comprises an iPhone, which runs the control algorithm, and a Dexcom continuous glucose monitor (CGM) connected by a custom hardware interface that displays the CGM readings and insulin and glucagon doses. Both the insulin and the glucagon are delivered subcutaneously by t:slim infusion pumps (Tandem Diabetes Care).
The system allows for announcement of meals prior to eating to trigger a partial meal-priming insulin bolus.
Patients received 5 days of bionic-pancreas treatment and 5 days of usual pump therapy in random order.
Adult Study: Differences Were More Pronounced at Night
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Dr. Steven J. Russell
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In the adult study, the 20 participants (aged 21 and older) lived at home during the usual-care period and carried out their normal activities while wearing their own insulin pump and their own CGM if desired. During the bionic-pancreas period, they stayed in a hotel and were allowed to move freely within a 3-mile area in Boston, accompanied by a staff member.
From www.medscape.com
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