London | Artificial pancreas – a device which monitors blood glucose in patients with diabetes and automatically adjusts levels of insulin entering the body – is likely to be available by 2018, scientists say.
Currently available technology allows insulin pumps to deliver insulin to people with diabetes after taking readings from glucose meters, but these two components are separate. It is the joining together of both parts into a ‘closed loop’ that makes an artificial pancreas, researchers said.
The actual timeline to availability of the artificial pancreas, as with other medical devices, encompasses regulatory approvals of regulatory agencies such as the US Food and Drug Administration (FDA), which is currently reviewing one proposed artificial pancreas with approval possibly as soon as 2017.
A recent review by the UK National Institute of Health Research reported that automated closed-loop systems may be expected to appear in the European market by the end of 2018.
In trials to date, users have been positive about how use of an artificial pancreas gives them ‘time off’ or a ‘holiday’ from their diabetes management, since the system is managing their blood sugar effectively without the need for constant monitoring by the user, said Roman Hovorka and Hood Thabit of the University of Cambridge in the UK.
One part of the clinical need for the artificial pancreas is the variability of insulin requirements between and within individuals – on one day a person could use one third of their normal requirements, and on another three times what they normally would. This is dependent on the individual, their diet, their physical activity and other factors, researchers said.
The combination of all these factors together places a burden on people with type 1 diabetes to constantly monitor their glucose levels, to ensure they do not end up with too much blood sugar or more commonly, too little. Both of these complications can cause significant damage to blood vessels and nerve endings, making complications such as cardiovascular problems more likely.
There are alternatives to the artificial pancreas, with improvements in technology in whole pancreas transplantation and also of just the insulin-producing beta cells. However, recipients of these transplants require drugs to suppress their immune systems. The artificial pancreas avoids the need for major surgery and drugs.
A number of clinical studies have been completed using the artificial pancreas in its various forms, in various settings such as diabetes camps for children and home testing. Many of these trials have shown as good or better glucose control than existing technologies.
A number of other studies are ongoing, researchers said. Prolonged 6- to 24-month multinational closed-loop clinical trials and pivotal studies are underway or in preparation including adults and children, researchers said.