People with type 1 diabetes need insulin to maintain their blood glucose levels. A new bionic pancreas uses next-generation technology to automatically deliver insulin, requiring less user input and providing more automation for patients.
This is because the device can automatically adjust insulin doses based on the patient’s blood glucose (sugar) levels measured using a continuous glucose monitor.
A clinical trial, conducted at 16 clinical sites across the United States, examined the use of this device by comparing it with standard care, which involved receiving insulin either by injection or pump, and the use of a continuous glucose monitor.
Published in the New England Journal of Medicine, the research enrolled 326 participants ages 6 to 79 years who had type 1 diabetes and had been using insulin for at least 1 year.
Participants were randomly allocated to a treatment group using the bionic pancreas or a standard-of-care control group that continued with their pre-trial method of glucose monitoring and insulin dosing.
During the study, participants using the bionic pancreas no longer needed to count carbohydrates or inject insulin to correct their high blood glucose levels as the device detected blood glucose and then calculated and delivered the insulin required.
Dr. Philip Raskin, professor of internal medicine at UT Southwestern Medical Center, one of the study investigators, explained the key findings, telling Medical News Today that “individuals with type 1 diabetes [now] have a device that can help them keep excellent control of their diabetes, something that was close to impossible before.”
In participants using the bionic pancreas, glycated hemoglobin improved from 7.9% to 7.3%, yet remained unchanged among the control group.
Glycated hemoglobin is a measure of a person’s long-term blood glucose control, also called the hemoglobin A1c test.
In addition to a healthy diet and exercise, the monitoring of blood glucose and taking insulin as required are key aspects of managing type 1 diabetes. However, it can be challenging to keep blood glucose levels within the appropriate range.
In the trial, participants in the bionic pancreas treatment group spent 11% more time, approximately 2.5 hours per day, within the targeted blood glucose range when compared to the control group.
Prof. Frank Joseph, a diabetes, endocrinology, and internal medicine specialist in the National Health Service, United Kingdom, and founder of DAM Health, not involved in the research, noted that:
“The bionic pancreas, as used in the trial, helped people who have type 1 diabetes to achieve a better level of control of their diabetes by having more time in [the] target range. What we mean by ‘target range’ is where your blood glucose levels should ideally be, and that is what the bionic pancreas offers, compared to the standard treatment for people which is currently where you inject insulin into their body four times a day.”
Dr. Nora Lansen, primary care physician and virtual clinical director with Galileo, also not part of the trial, added that “the potential for human error when calculating insulin needs is real.”
“Having an automated system to remove some of that calculating could really increase accuracy,” she noted, “and decrease the risk of adverse outcomes from overdoing it with insulin [which leads to hypoglycemia] or chronically underdosing — poorly controlled [diabetes] leads to all sorts of bad outcomes, including diabetic ketoacidosis, which can be fatal.”
The most frequently reported adverse event in the bionic pancreas group was hyperglycemia (high blood sugar), caused by problems with insulin pump equipment. Yet, importantly, the frequency of severe hypoglycemia was not statistically different between the two groups.
Nevertheless, the number of mild hypoglycemia events, or low blood glucose, was low and was not different between the groups.
Dr. Raskin noted that “there were issues with the patients using the device. The first was some difficulties filling the syringe with insulin. Some patients were impatient as the pump delivered insulin around meals slower than the patient could do using a syringe.”
As it is a new technology, researchers expect that further testing of the bionic pancreas will be required. Patients will require support in using the device and healthcare providers will require training.
Dr. Lansen raised an important question to MNT, asking whether the findings of this trial are broadly applicable.
“The patients enrolled in the study started with a pretty tight A1c (7.7%) [glycated hemoglobin] and they had already been on an insulin regimen for a year,” Dr. Lansen said.
“I’d be interested to see how patients would respond to the bionic pancreas when starting off in a state of much worse glucose control. Separately, I wonder why the control group in this study didn’t budge. We would expect at least some dip in A1c over 13 weeks in a group receiving standard care,” she pointed out.
Prof. Joseph agreed, telling MNT that “there is still a way to go to make sure the bionic pancreas is absolutely safe and secure. There were some patients in the study where the blood sugar kept going up because the canula got blocked. But when you have a technology that can alert you that your sugar levels are going up, allowing you to intervene, put a new canula in and get back on track, this can obviate these issues, so there is always going to be a degree of vigilance needed.”
Overall, this research shows the promise of this new technology and its applications for patients. Further research is needed, but in time this technology may one day replace the current standard of care.
“The bionic pancreas is it is another step closer for patients with type 1 diabetes to start living lives where they don’t have to be hypervigilant checking their blood glucose and blood sugar levels all the time and worrying about the levels fluctuating constantly. The technology allows this to happen more easily, without the patient constantly thinking about their diabetes and, in turn; what they are going to eat, what their blood sugar is; how much insulin they should take, and stopping them injecting four times a day. That is a big advantage.”
– Prof. Frank Joseph



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