Artificial pancreas trials to begin in the U.S.

The pancreas is responsible for producing a range of hormones within our body, including insulin, which helps to control the levels of sugar (glucose) in our blood. Those who do not manage to control their blood sugar level – by either not producing enough insulin (type 1) or by producing ineffective insulin (type 2) – tend to develop hyperglycemia.

Frequently injecting insulin is the normal method of treatment, but there are increasingly more advanced methods being trialled and tested in medical laboratories and institutions across the world. Just this week, a team of researchers in California have developed insulin-producing beta cells by manipulating the development of human skin cells; these can be transplanted straight into mice, where they are shown to be effective at preventing the onset of diabetes.

Now, a new research collaborative between Harvard University and the University of Virginia School of Medicine is about to begin a long-term clinical trial that will test their artificially created pancreas on patients with type 1 diabetes. Over the course of six months, 240 people suffering from the condition in the U.S. will be given the device, and medical staff will monitor how their blood sugar levels respond to it.

Unlike a regular organ transplant, this artificial pancreas is essentially wearable technology that will be externally based. This device, created using nearly $13 million (£9 million) of funding from the National Institutes of Health, is an automated insulin delivery system designed to act as the body’s glucose-regulating function.

An insulin pump and blood sugar level monitor is first placed under the skin, which is wirelessly connected to a smartphone. Advanced computational software carefully monitors the blood sugar level, and when it gets too high, insulin contained within the device is injected into the patient, painlessly. The device also measures the patient’s sleep patterns, stress levels, metabolism, nutrient levels, and their general physical activity, allowing it to over time make increasingly accurate predictions as to when an injection is required.

“The idea is that this can lead to an improved quality of life for individuals with this disease – not a solution to diabetes, but a means to really extend the quality of their healthful living,” said Francis J. Doyle III, co-principal investigator and engineering lead on the project.

A regular diabetes sufferer has to regularly monitor their own blood sugar levels; if they are ever distracted and miss a dose, they put themselves at incredible risk of developing life-threatening hyperglycemia, among other conditions. This new device does all this work for them. Instead of aiming to keep glucose levels at a precise value, the algorithm on the smartphone software calculates an appropriate blood sugar range that the device then maintains.

Over the course of this trial, the algorithm will discover patterns within the behavior of a range of humans, which will improve the device’s ability to treat inherently unpredictable people in the long term.