The artificial pancreas, a device which monitors blood glucose in patients with type 1 diabetes and then automatically adjusts levels of insulin entering the body, is likely to be available by 2018, conclude authors of a paper in Diabetologia.
Issues such as speed of action of the forms of insulin used, reliability, convenience and accuracy of glucose monitors plus cyber security to protect devices from hacking, are among the issues that are being addressed.
The amount of insulin they need at any given moment is always changing, day to day, hour to hour, even minute to minute.
Insulin is the hormone that allows your body’s cells to absorb glucose, the gasoline that makes cells go.
Damiano serves as CEO but remains a professor at Boston University, where he continues to seek research grants from NIH. Currently, available technology allows insulin pumps to deliver insulin to people with diabetes after taking a reading or readings from glucose meters, but these two components are separate.
It is the joining of both parts into a ‘closed loop’ that makes an artificial pancreas.
In trials to date, users have been confident about how the 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.
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 standard requirements, and on another three times what they normally would.
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 don’t 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 both whole pancreas transplantation and also transplants of just the beta cells of the pancreas which produce insulin.
In the case of whole pancreas transplantation, major surgery is required; and in beta cell islet transplantation, the body’s immune system can still attack the transplanted cells and kill off a large proportion of them.
The artificial pancreas, of course, avoids the need for major surgery and immuno-suppressant drugs.
Researchers globally continue to work on some challenges faced by artificial pancreas technology.
One such challenge is that even fast-acting insulin analogues do not reach their peak levels in the bloodstream until 0.5 to 2 hours after injection, with their effects lasting 3 to 5 hours.
Work also continues to improve the software in closed loop systems to make it as accurate as possible in blood sugar management.
Some clinical studies have been completed using the artificial pancreas in its various forms, in various settings such as diabetes camps for children, and real life home testing.
The authors say: “Prolonged 6- to 24-month multinational closed-loop clinical trials, and pivotal studies are underway or in preparation including adults and children. As closed loop devices may be vulnerable to cyber security threats such as interference with wireless protocols and unauthorized data retrieval, implementation of secure communications protocols is a must.”
The actual timeline for the availability of the artificial pancreas, as with other medical devices, encompasses regulatory approvals with reassuring attitudes of regulatory agencies such as the US Food and Drug Administration, which is currently reviewing one proposed artificial pancreas with approval possibly as soon as 2017.
A recent study by the UK National Institute for Health Research reported that automated closed-loop systems might be expected to appear in the market by the end of 2018.
The authors say: “This timeline will largely be dependent upon regulatory approvals and ensuring that infrastructures and support are in place for healthcare professionals providing clinical care. Structured education will need to continue to augment efficacy and safety.”
