Artificial Pancreas Could Improve Outcomes in Diabetes
The first of 4 new clinical trial of artificial pancreas systems has begun, which could benefit patients with type 2 diabetes.
The National Institutes of Health (NIH) recently started the first of 4 separate research efforts to evaluate and revise artificial pancreas systems.
If the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) studies successfully provide new insights, patients with type 2 diabetes will be able to access this potentially life-changing device. This research is one of the last steps before seeking regulatory approval for the use of the permanent device in these patients.
The artificial pancreas is a system that monitors blood glucose levels, and administers insulin or a combination of insulin and another hormone, in response to the levels, according to the NIH.
The system would completely replace fingerstick testing, glucose monitoring systems, or other methods of insulin delivery.
“These studies aim to collect the data necessary to bring artificial pancreas technology to the people who need it,” said Guillermo Arreaza-Rubín, MD, director of NIDDK’s Diabetes Technology Program. “Results from these studies could change and save lives.”
In previous studies, researchers and patients worked together to evaluate the short-term use of artificial pancreas devices in children with type 1 diabetes.
The FDA approved a hybrid model of an artificial pancreas in 2016. This system senses rising glucose levels at mealtimes and throughout the day, and adjusts insulin levels accordingly, the NIH reported.
In the previous trials, the artificial pancreas was observed to reduce the burden of disease management on patients and their caregivers. The device also resulted in more optimal glucose levels compared with standard treatment.
Controlling blood glucose levels early on may help reduce complications, such as nerve, eye, and kidney diseases, according to the NIH.
The new research is expected to begin by 2018, and will include a larger group of patients using the device over a longer period time in real-world settings. Study participants will be asked to monitor themselves, but go about their day-to-day life normally as they are monitored remotely by investigators.
“Managing type 1 diabetes currently requires a constant juggling act between checking blood glucose levels frequently and delivering just the right amount of insulin while taking into account meals, physical activity, and other aspects of daily life, where a missed or wrong delivery could lead to potential complications,” said Andrew Bremer, MD,PhD, the NIDDK program official overseeing the studies. “Unifying the management of type 1 diabetes into a single, integrated system could lift so much of that burden.”
The new studies will explore safety, efficacy, user-friendliness, physical and emotional health, and costs associated with different artificial pancreases in patients in the United States and in other countries.
“For many people with type 1 diabetes, the realization of a successful, fully automated artificial pancreas is a dearly held dream. It signifies a life freer from nightly wake-up calls to check blood glucose or deliver insulin, a life freer from dangerous swings of blood glucose,” said Griffin P. Rodgers, MD, MAPC, NIDDK director. “Nearly 100 years since the discovery of insulin, a successful artificial pancreas would mark another huge step toward better health for people with type 1 diabetes.”