Study Gains Put Diabetics Nearer to Artificial Pancreas

A decade of work by scientists to create an artificial pancreas that will independently control insulin levels in people with Type 1 diabetes took a leap forward in research from Medtronic Inc. and Johnson & Johnson.

Medical pumps developed by the two companies were shown in separate studies this weekend at the American Diabetes Association meeting in Chicago to successfully sense changes in blood sugar levels and adjust insulin delivery accordingly. Today, Medtronic said it’s taking the next step in its product’s development with the start of a feasibility trial testing a fully automated artificial pancreas system.

Type 1 diabetes occurs when insulin-releasing beta cells in the pancreas are destroyed. Patients must test their blood repeatedly with finger sticks or a glucose monitor, then inject themselves with the hormone using a needle or pump to control blood sugar. The emerging artificial pancreas technology seeks to link a glucose monitor, or sensor, to a pump that delivers insulin on its own as needed, mimicking a healthy pancreas.

“We’re a few years away at least, maybe five years, from a fully operational artificial pancreas,” Les Funtleyder, a health strategist with investment firm Poliwogg LLC in New York, said in a telephone interview. “We’re getting smarter about the rhythms and the technology and I think the sensors may be the most important thing,” he said.

Lifelong Management

About 5 percent of the 25.8 million Americans with diabetes have the Type 1 form, which is most often diagnosed in young people and requires lifelong management of the disease. Poor blood sugar control can led to complications including heart disease, nerve and kidney damage, blindness and amputations.

Safely automating and perfecting blood sugar control would be a major advance for Type I diabetics, said Bruce Buckingham, a pediatric endocrinologist at Stanford Medical Center in California, in a telephone interview.

“If you’re a parent, you’re getting up and checking your kid overnight,” for low blood sugar, he said. “Parents of younger children may get up at midnight and 3 a.m. to make sure their child’s OK. If you’re an adult, it’s harder. You don’t have that parent around to be your angel guardian overnight.”

Almost one-third of Type 1 diabetics now use continuous glucose monitors and the number should grow as improvements lead to better control, said Aaron Kowalski, vice president of treatment therapies at JDRF, a New York-based advocacy group. The market for the monitors sold by Medtronic and DexCom Inc., as well as the insulin pumps that replace repeatedly daily injections, is about $2.4 billion annually.

Suspend Function

A feature in the “smart” pump developed by Minneapolis-based Medtronic stops insulin delivery for two hours when blood sugar drops to a dangerous level. The condition, known as hypoglycemia, can cause seizures, loss of consciousness and death. Use of the suspend function slashed low blood-sugar levels by one-third at night, when patients are largely unaware of the problem or too impaired to respond to it.

“Automating any insulin delivery can be a win for the patient,” said Francine Kaufman, vice president of global medical affairs in Medtronic’s diabetes business, in a telephone interview. “It doesn’t take much more than intuition to know that stopping insulin when someone is on their way to being too low is a good thing.”

FDA Filing

Medtronic has filed for U.S. Food and Drug Administration approval of its pump, called MiniMed 530 G, and expects clearance by the end of the year, Lawrence Biegelsen, an analyst with Wells Fargo, wrote in a June 19 research note. The pump has been sold outside of the U.S. since 2009 as the MiniMed Veo.

Today Medtronic announced that it began enrolling patients in a feasibility trial testing a fully automated artificial pancreas system. The system requires no interaction from the user, automatically adjusting insulin delivery to a specific glucose level. The overnight study will include 85 patients, Medtronic said today in a statement.

The device from New Brunswick, New Jersey-based J&J, the world’s biggest maker of health-care products, was tested in an early study of 20 adults with Type 1 diabetes. It showed it’s possible to monitor, measure and deliver the appropriate amount of insulin through a single system.

The Medtronic study, also published in the New England Journal of Medicine, shows the novel pump doesn’t cause harm or spike blood sugar levels by turning off the insulin temporarily. An alarm sounds when the low blood-sugar level is hit, and the patient can take other action, like eating or drinking, to correct the problem.

Research Goal

About half the time the insulin was stopped for just 10 minutes, according to the research.

“We met every goal we were trying to accomplish with the study,” said Rich Bergenstal, a principal investigator of the Medtronic “Aspire” study and executive director of the International Diabetes Center at Park Nicollet in St. Louis Park, Minnesota, in a telephone interview. “There’s every reason to think this should be very approvable.”

Johnson & Johnson’s research also focused on the 9 p.m. to 7 a.m. period, when episodes of low blood sugar can be deadly. It found use of the device kept glucose levels in the recommended range for more than 90 percent of the night.

The system uses a computer algorithm and readings from a continuous glucose monitor to calculate the amount of insulin a patient will need to ensure their blood sugar remains in a safe range. Fewer than half the volunteers had their levels drop into dangerous territory and there were no unexpected safety issues, according to the report at the diabetes meeting.

Algorithm Capabilities

“We are feeling very confident with the data we have gotten so far in understanding the capabilities of the algorithm, the risks associated with it and the features we want,” said Ramakrishna Venugopalan, director of research and development at J&J’s division that’s developing the device, called Animas.

The study was conducted during a closely monitored overnight visit using machines built for the clinical trial process. Animas has received approval to conduct a third feasibility study of its approach to look for any flaws before it begins trials that will allow patients to live at home for weeks or months with the automated system, Venugopalan said.

Over the last six to nine months, the FDA has accelerated research in the field, said Buckingham, the pediatric endocrinologist from Stanford.

“For a number of years the FDA was a subject of concern among the diabetic community, that things weren’t happening faster,” he said. “I’ve seen a big acceleration lately; they’ve been moving things forward.”

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