New data on the "artificial pancreas" in type 2 diabetes



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The device, which variants were used to treat type 1 diabetes, maintained blood glucose levels in the target area more consistently than the control group, none of them receiving intensive care. In future generations, experts believe that this technology could improve health outcomes and reduce the workload of doctors and nurses who manage glucose levels for the millions of diabetic patients hospitalized each year.

"This system simply responds to rising and falling glucose," said study author Roman Hovorka, director of research at the University of Cambridge Metabolic Research Laboratories.

"The blood glucose control at the hospital is not particularly good, and it is absolutely necessary to solve this problem," said Dr. Steven Russell, associate professor of medicine at Massachusetts General Hospital and at the Harvard Medical School. Russell, who was not involved in the new study, is studying automatic glucose regulation on a project known as the Bionic Pancreas.

These machines "give data every five minutes and we can not substitute someone to make decisions as often," Russell added.

"It's a process that lends itself to automation."

Closed loop

More than 30 million adults in the United States have diabetes, according to the United States Centers for Disease Control and Prevention. It is the seventh leading cause of death and the leading cause of kidney failure, according to the agency.

Type 1 diabetes is an autoimmune disease in which the pancreas does not produce a lot of insulin, a hormone that your body needs to balance glucose in the blood. In type 2 diabetes, which develops over many years and has been linked to obesity, the body becomes less sensitive to insulin.

Type 1 diabetes is usually harder to control than Type 2 because glucose levels change faster in the first, said Russell.

& # 39; Artificial pancreas & # 39; for type 1 diabetes, the FDA approval

If the blood sugar level is too high or too low, it can lead to a multitude of complications, including kidney damage, nervous problems and diabetic comas.

"In health care settings … you would presume that you get the best possible care for all your medical conditions," said Dr. Jennifer Sherr, Pediatric Endocrinologist and Associate Professor at the School of Medicine at the # Yale University. Sherr has not participated in the new study, but she has studied similar insulin delivery systems and, as a person with type 1 diabetes, uses an automated system herself .

"The hospital staff is taxed with a number of patients, it is difficult to ensure that insulin administration is timely when meals arrive in the rooms, and that the stress and d & # 39; Other factors come into play, "she said.

Havorka's "closed-loop insulin delivery" system, as it is technically called, used a real-time blood glucose sensor and a pump that released a fast-acting insulin drug under the skin. . These devices communicate wirelessly with a tablet computer running a predictive algorithm.

The system maintained 70 glucose levels in the target range 65.8% of the time, compared to 41.5% of the time for the 66 in the control group – a difference of about 24 percentage points.

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"It's a bigger leap than most other closed loop studies," Sherr said.

The study was conducted in two hospitals in Europe: the Addenbrooke Hospital in Cambridge, UK, and the University Hospital in Bern, Switzerland. Patients were followed up to 15 days or until they came out of the hospital.

By controlling glucose with insulin, patients run the risk of getting critical hyperglycemia, or hypoglycemia, experts say. Although new research did not show a statistical difference between how long glucose levels plummeted too low in one or the other group, Russell said that the study might have missed the wide and diverse patient population she needed to prove this point. Yet, none of the patients in the study experienced severe hypoglycemic episodes, the authors wrote.

Both groups received roughly the same amount of insulin on average. Hovorka said it was evidence that insulin was delivered more efficiently and with better timing, meeting the individual needs of patients.

"The promise of the artificial pancreas in general is to provide insulin when it is needed and in the right amount," Russell said.

The search for what triggers type 1 diabetes

Several patients reported skin irritated by sensor adhesive and bruising where the tube was inserted, according to the study. The researchers also reported "sensor failures in two patients and a pump control error in one patient".

"To be able to use this technology widely in the clinic, some of these technological problems will need to be improved," Hovorka said. "These problems are being fixed, but … it's not the technology that is foolproof."

Russell said that "the system is clearly not ready for commercial use in its current form", but it offers an important proof of principle.

"I would say that a system that has a rare failure rate and better overall blood sugar control would be an improvement over the current situation, which also has failures of a different type" said Russell.

"Even if the system is not 100% perfect, which is not the case, it will probably be even better than the current way of doing things."

A pancreas by another name

Experts say the "artificial pancreas" does not completely match its biological counterpart.

"It mimics important functions of the pancreas, but not all the function of the pancreas," said Hovorka.

The pancreas produces other hormones beyond insulin, like another called glucagon, and its distinct roles in the digestion of foods are not usually affected by diabetes, Russell said.

Sherr says that she tends not to use the term "artificial pancreas" because some patients, like the children she works with, may mistakenly believe that she requires invasive surgery.

Hovorka said that the wider use of an "artificial pancreas" in type 2 diabetes will require further research on how the device affects health outcomes, such as the length of hospital stays and infection rates and other complications. But its wider use can ultimately be summed up as whether it is profitable, he said.

"It's more of a health economy than the actual treatment," Hovorka said. "I think the potential for improving glucose control is definitely there."

Russell said that such a system could ultimately be effective for "a subgroup of patients with type 2 diabetes," such as those who take multiple daily injections of long-acting and action-insulins. brief. Their diabetes may be harder to control, he says, and they are more likely to suffer from complications of diabetes, such as amputations, vision and kidney problems.

Even inside the hospital, studies like this can be "reassuring" for people with diabetes who could unexpectedly be hospitalized someday, Sherr said.

"Nobody plans to become extremely sick," she said. "As we go through these experiences in life, we [hope to] get the best care from us. "

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