Researchers at the University of Cambridge successfully trialled an “artificial pancreas” with 26 patients with type 2 diabetes.
Artificial pancreas for type 2 diabetes: Researchers at the University of Cambridge have successfully conducted the trial of artificial pancreas on 26 patients with type 2 diabetes. During the trial, researchers found that the device doubled the time that the patients were in the target glucose range compared to conventional treatment. Also, it halved the time that the patients spent experiencing high glucose levels. .
According to a research article published in the Indian Journal of Ophthalmology, an estimated 77 million people in India had type 2 diabetes in India in 2019, and that number is projected to grow to 134 million by 2045. Usually, blood sugar levels are controlled by the production of insulin in the body but for patients with type 2 diabetes, its production is disrupted.
Over time, this can cause serious health issues including eye, kidney and nerve damage, and heart disease. Usually, type 2 diabetes is managed through a combination of lifestyle changes and medication aimed at keeping blood sugar levels low.“The artificial pancreas involves an insulin pump controlled by an algorithm, which predicts how much insulin an individual will need in response to glucose levels, and automatically adjusts the amount accordingly. The device combines an off-the-shelf glucose sensor and insulin pump with an app that we developed, known as CamAPS HX,” Charlotte Boughton, who co-led the study published in Nature Medicine.
Unlike a standard insulin pump, users with the “artificial pancreas” do not need to manually adjust the pump settings depending on the glucose levels, according to Boughton. But the patients could monitor the device using the CamAPS HX app on their smartphones. “The app is designed to be interoperable and to work with different approved insulin pumps and glucose sensors,” added Boughton. The app automatically adjusts to the lifestyle changes of the patients and learns to predict how much insulin each individual will need to keep glucose in the target range.
Before the trial, the same research team had shown that an artificial pancreas run by a similar algorithm is effective for adults and young children living with type 1 diabetes. Earlier, they had also successfully conducted a trial of the device on patients who have type 2 diabetes and need dialysis.
Artificial pancreas trial
For the trial, the researchers recruited 26 patients from the Wolfson Diabetes and Endocrine Clinic in Cambridge along with a local group of GP surgeons. The patients were randomly allocated to two groups. The first group used the device for eight weeks and later switched to standard therapy while the second group took the control therapy first before switching to the artificial pancreas after eight weeks.
The teams used various measures to assess how effectively the artificial pancreas worked. One was the proportion of time that the patients spent with their glucose levels within a target range between 3.9 and 10.0 millimoles per litre. The researchers found that on average, patients using the device spent two-thirds of the time within the target range, which is almost double the time they spent within the range while on the control treatment.
The next parameter measured by the team was the proportion of time spent by the patients with high glucose levels above 10 millimoles per litre. Patients who were taking the control therapy spent two-thirds of their time with high glucose levels while those using the artificial pancreas device only spent one-third of their time with high glucose levels.
Further, the artificial pancreas system was also able to reduce levels of glycated haemoglobin. When haemoglobin, a protein in red blood cells that carries oxygen, joins with the glucose in blood, it becomes “glycated,” leading to the creation of glycated haemoglobin. Average glycated haemoglobin levels for the patients were at 8.4 per cent during the control therapy and 7.3 per cent while using the artificial pancreas.
More importantly, no patients experienced hypoglycaemia, or dangerously low levels of blood sugar, during the trial. According to Aideen Daily, co-author of the research, one of the barriers to further widespread adoption of insulin therapy is the fear of severe hypoglycaemia. While no patients suffered from severe hypoglycaemia, one patient using the artificial pancreas had to be admitted to the hospital due to an abscess at the site of the pump cannula.
Patient response and further research
According to the researchers, feedback from the patients who were part of the trial suggests that they were happy to have their glucose levels controlled automatically. As many as 89 per cent of the patients said that they spent less time managing their diabetes when using the device. One major downside reported by the patients was the increased anxiety over hypoglycaemia.
“We now plan to carry out a much larger multicentre study to build on the findings. We do not anticipate any new potential risks in future studies or in the potential commercial application of this technology, but wider use will confirm safety in a broader population,” said Boughton while elaborating on the plans for future research. The research team has also submitted the device for regulatory approval and hopes to make it commercially available for patients with type 2 diabetes.