"Artificial Pancreas" System Performs Well in Home-Based Trial, Researchers Report

Patients whose blood sugar and insulin delivery was managed by software had been control than those who had to self-monitor their insulin delivery.

An algorithm-driven “artificial pancreas” system worked safely in a 3-month trial involving adults and children with type 1 diabetes (T1D), according to results presented Thursday at the European Association for the Study of Diabetes (EASD) in Sweden.

The trial involved 33 adults and 25 children and teens; adults used the system day and night and the younger patients used it overnight. Researchers reporting simultaneously in the New England Journal of Medicine concluded that the system, which makes use of smartphone technology and software that continuously monitors blood sugar and insulin delivery, produced better results that the current standard of sensor-aided pump therapy.

The so-called “closed loop” system “improved glucose control, reduced hypoglycemia, and, in adults, resulted in a lower glycated hemoglobin level,” the authors wrote.

"We found that extended use of a closed-loop system at home over a period of 12 weeks during free daily living without close supervision is feasible in adults, children, and adolescents with type 1 diabetes," the authors continued, led by Hood Thabit, MD, of the University of Cambridge in Britain. "We did not restrict participants' dietary intake or, after the initial 2 weeks, physical activity or geographical movements. Participants were allowed to travel and to use the system when driving."

About 5% of the 29 million Americans with diabetes have T1D, which occurs when the body kills cells in the pancreas that produce insulin and glucagon that regulate blood glucose levels. When blood glucose is elevated, especially for extended periods, this leads to blood vessel damage in the eyes and extremities. Acute cases of low blood sugar levels can cause patients to lose consciousness or die, while poor management of the disease over time can cause blindness, kidney damage or loss of limbs.

Management of type 1 disease is quite time consuming and requires daily attention to diet, exercise and constant monitoring of blood sugar levels. Patients who have T1D are known to experience stress and depression from the constant vigilance required to maintain their health. For many years, researchers have pursued development of a so-called “artificial pancreas” that would free patients from the constant need to monitor blood sugar levels; this would represent not only a huge step forward in health maintenance, but also quality of life.

The technology presented at EASD appears to be a step toward that goal. In the portion of the study involving the adults, glucose levels stayed in the target range of 70 to 180 mg/dL 68% of the time when the software controlled the release, compared with 57% of the time when the volunteers controlled their insulin release.

The authors said that patients with the algorithm-driven technology experienced more consistent glucose control despite the “day-to-day variability in insulin requirements.” Authors said the new system represented an advance even over new technology that has reached the market in recent years.

“Systems with threshold-suspend control and predictive low-glucose suspend control may reduce the risk of hypoglycemia, but the systems are not designed to step up insulin delivery and do not address the issue of hyperglycemia,” the authors wrote. “The advantage of a closed-loop system is the responsive, graduated modulation of insulin delivery, both below and above the preset pump regimen, which allows for improvements in the proportion of time spent in target glucose range and the lowering of the mean glucose level without increasing the risk of hypoglycemia.”

Researchers reported just 1 incident of hypoglycemia, which was attributed to a dying battery in a device.

Aaron Kowalski, vice president of research for JDRF, said the results showed the technology was “potentially transformative.” JDRF has been a leading funding source for this artificial pancreas project and others, which means that multiple competitors are racing toward a commercially viable product.

Kowalski said there had always been concerns about what happens when users of the technology “go out in the real world where you have exercise, you might be golfing all day, eating huge meals, and drinking alcohol.” The study presented Thursday shows that not only does the artificial pancreas technology work, but it’s safer than what most patients are doing now.

Reference

Thabit H, Tauschmann M, Allen JM. Home Use of an artificial beta cell in type 1 diabetes. N Engl J Med [published online September 17, 2015]. 2015. DOI: 10.1056/NEJMoa1509351.