Sufferers of type 1 diabetes are required to constantly monitor their blood glucose levels and administer insulin as needed. But the daily hassle of self-care for patients could soon be reduced, with a new study concluding that automated "artificial pancreas" systems could be available in as little as two years.
The study, authored by Doctors Roman Hovorka and Hood Thabit of Cambridge University, reviews the overall progress of technology in these automated systems, including the bionic pancreas being developed by Boston University scientists.
Currently, treatment for type 1 diabetes generally requires two separate processes. Patients need to manually monitor their blood glucose levels several times a day with a fingerstick blood test, and if readings are high they may need to use an insulin pump. These pumps are automated devices which clip to clothing and administer a base-line level of insulin through a catheter under the skin, with patients manually telling the pump to inject additional doses when they eat.
The artificial pancreas combines those two separate processes into one "closed-loop" system. A needle under the skin continuously monitors blood glucose levels and automatically administers insulin as required, removing the burden of patient self-care and ensuring a more consistent glucose level than current pumps.
Automating those functions also helps overcome another disadvantage of pumps that rely on a longer-acting basal insulin: a patient's insulin requirements can vary significantly day-to-day, and different people will have different needs. Depending on diet and physical activity, among other factors, a patient might only use one third of their normal requirement one day, and up to three times more than normal the next. An artificial pancreas will read those fluctuations and react accordingly, and the study lists this as the key advantage of closed-loop systems.
Clinical trials of artificial pancreas systems over the past few years have been conducted in diabetes camps and outpatient settings, as well as remotely supervised, "free-living" tests at home. Many of these studies have found that closed-loop systems are effective in maintaining the ideal glucose range, and reducing the amount of time patients spend in a state of hypoglycaemia, when blood sugar is too low. The patients involved in these studies have been excited by the technology, too.
"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," say the paper's authors.
Artificial pancreases are also shown to be more viable than procedures like transplants of either the whole pancreas, or the beta cells responsible for insulin production. Not only are these surgeries invasive, but patients run the risk of rejection and further complications.
Of course, there are still areas where artificial pancreas systems could be improved, and the study calls for further research to overcome these challenges. For example, it can still take between half an hour and two hours after injection for the insulin to reach peak levels in the bloodstream, which may be too slow in some circumstances. Research is being conducted into faster-acting types of insulin, such as insulin aspart and inhaled forms.
These artificial pancreas systems could be on the market sooner rather than later. The US Food and Drug Administration (FDA) is currently reviewing a proposal of one such system, which could be approved as soon as next year. Meanwhile, a report by the UK National Institute for Health Research predicts that closed-loop systems may be available by the end of 2018.
The study appeared in the journal Diabetologia.
Source: Diabetologia via Eurekalert