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An artificial pancreas may soon help people with type 2 diabetes who also need kidney dialysis. Tests conducted by the University of Cambridge and the Inselspital, University Hospital Bern, Switzerland, show that the device can help patients safely and effectively manage their blood sugar levels and reduce the risk of hypoglycemia.
Diabetes is the most common cause of kidney failure, accounting for just under a third (30%) of cases. As the number of people living with type 2 diabetes increases, so does the number of people requiring dialysis or kidney transplants. Kidney failure increases the risk of hypoglycemia and hyperglycemia – abnormally low or high blood sugar levels respectively – which in turn can lead to complications ranging from dizziness to falls and even coma.
Managing diabetes in patients with renal failure is a challenge for both patients and healthcare professionals. Many aspects of their care are poorly understood, including blood sugar goals and treatments. Most oral diabetes medications are not recommended for these patients, so insulin injections are the most commonly used treatment for diabetes – although optimal insulin dosing schedules are difficult to establish.
A team from the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust has already developed an artificial pancreas to replace insulin injections for patients living with type 1 diabetes. In research published today in Natural medicine, the team – in collaboration with researchers at the University Hospital of Bern and the University of Bern, Switzerland – showed that the device can be used to help patients with both type 2 diabetes and kidney failure.
The artificial pancreas is powered by software in the user’s smartphone that sends a signal to an insulin pump to adjust the level of insulin the patient is receiving. A blood glucose meter measures the patient’s blood sugar and sends it back to the smartphone for further adjustments.
Unlike the artificial pancreas used for type 1 diabetes, this version is a fully closed loop system – whereas patients with type 1 diabetes have to tell their artificial pancreas that they are about to eat to allow the Adjustment of insulin, for example, with this new version they can let the device operate fully automatically.
Dr Charlotte Boughton of the Wellcome Trust-MRC Institute of Metabolic Science at the University of Cambridge, who led the study, said: Potentially dangerous high or low blood sugar levels can be a challenge. There is a real unmet need for new approaches to help them manage their disease safely and effectively.
The artificial pancreas is a small, portable medical device designed to perform the function of a healthy pancreas by controlling blood sugar levels, using digital technology to automate insulin delivery. The system is worn outside the body and consists of three functional components: a glucose sensor, a computer algorithm to calculate the insulin dose, and an insulin pump.
The team recruited 26 patients requiring dialysis between October 2019 and November 2020. Thirteen participants were randomized to receive the artificial pancreas first and 13 to receive standard insulin therapy first. Researchers compared how long patients spent in the target blood sugar range (5.6-10.0 mmol / L) over a 20-day outpatient period.
Patients using the artificial pancreas spent an average of 53% of their time in the target range, compared to 38% when using the control treatment. This was equivalent to about 3.5 additional hours per day spent in target range over control therapy.
The mean blood sugar was lower with the artificial pancreas (10.1 vs 11.6 mmol / L). The artificial pancreas reduced the time patients spent with potentially dangerously low blood sugar levels, or “hypos.”
The efficiency of the artificial pancreas improved significantly over the study period as the algorithm adapted, and the time spent in the target blood glucose range increased from 36% on the first day to more 60% on the twentieth day. This finding highlights the importance of using an adaptive algorithm, which can adjust in response to an individual’s changing insulin needs over time.
When asked about their experiences using the artificial pancreas, everyone who responded said they would recommend it to others. Nine in ten (92%) said they spent less time managing their diabetes with the artificial pancreas than during the control period, and similar numbers (87%) were less concerned about their blood sugar levels when they used it.
Other benefits of the artificial pancreas reported by study participants included less need for finger-prick blood sugar checks, less time needed to manage their diabetes, resulting in more personal time and freedom, and enhanced peace of mind and comfort. The downsides included discomfort when wearing the insulin pump and wearing the smartphone.
Lead author Professor Roman Hovorka, also from the Wellcome Trust-MRC Institute of Metabolic Science, said: “Not only did the artificial pancreas increase the time patients spent in the target range for blood sugar levels , but he had peace of mind. They were able to spend less time focusing on managing their condition and worrying about blood sugar, and more time living their lives. “
Dr Boughton added: “Now that we have shown that the artificial pancreas works in one of the most difficult patient groups to treat, we believe it may prove useful in the larger population of people living with it. type 2 diabetes. “
The team is currently testing the artificial pancreas for outpatient use in people with type 2 diabetes who do not need dialysis and exploring the system in complex medical situations such as perioperative care.
Dr Lia Bally, who co-led the study in Bern, said: “The artificial pancreas has the potential to become a key part of integrated personalized care for people with complex medical needs.”
The research was supported by the NIHR Cambridge Biomedical Research Center, the Novo Nordisk UK Research Foundation, the Swiss Society of Endocrinology and Diabetes, and the Swiss Diabetes Foundation and the Swiss Kidney Foundation.
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