‘Bionic pancreas’ better than standard care
- The new automated insulin delivery system, described as a “bionic pancreas,” monitors a person’s blood glucose levels using a glucose monitor and then automatically delivers insulin when needed using an insulin pump.
- This device replaces the need to test glucose levels using existing standard of care, such as fingerstick blood testing, multiple daily insulin injections, or other automated pumps.
- A new research study in people with type 1 diabetes shows that a bionic pancreas, tested against existing standards of care, is more effective at keeping blood glucose (sugar) levels within normal limits..
People with type 1 diabetes need insulin to maintain their own blood glucose levels. The 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 glucose (sugar) level as measured by a continuous glucose monitor.
The clinical trial, conducted at 16 clinical sites across the United States, examined the use of the device by comparing it to standard care, which included receiving insulin either by injection or pump, and using a continuous glucose monitor.
Published in New England Journal of MedicineThe study included 326 participants aged 6 to 79 who had type 1 diabetes and had been using insulin for at least a year.
Participants were randomly assigned to either a bionic pancreas group or a standard care control group that continued with pre-trial glucose monitoring and insulin dosing.
During the study, participants using the bionic pancreas no longer had to count carbohydrates or inject insulin to correct high blood glucose because the device has detected blood glucose and then calculated and delivered the required insulin.
Dr. Philip Raskinprofessor of internal medicine at UT Southwestern Medical Center, one of the study’s researchers, explained the key findings, saying Medical news today that “individuals with type 1 diabetes [now] they have a device that can help them maintain excellent diabetes control, something that was nearly impossible before.”
In participants using the bionic pancreas, glycated hemoglobin improved from 7.9% to 7.3%, but remained unchanged in the control group.
Glycated hemoglobin is a measure of a person’s long-term blood glucose control, also called hemoglobin A1c test.
In addition to a healthy diet and exercise, monitoring your blood glucose and taking insulin as needed are key aspects of managing type 1 diabetes. However, it can be challenging to keep your blood glucose levels in the appropriate range.
In the trial, participants in the bionic pancreas therapy group spent 11% more time, approximately 2.5 hours per day, within the target blood glucose range compared to the control group.
prof. Frank Josephdiabetes, endocrinologyand specialist in internal medicine at the National Health Service, United Kingdom, and founder of DAM Health, who was not involved in the research, noted that:
“The bionic pancreas, as used in the trial, helped people with type 1 diabetes achieve a better level of diabetes control by having more time in [the] target range. What we mean by ‘target range’ is where the blood glucose levels should ideally be, and that’s what the bionic pancreas offers, compared to the standard treatment for people where you currently inject insulin into their body four times a day.”
dr. Nora LansenA primary care physician and virtual clinical director with Galileo, who is also not part of the trial, added that “the potential for human error in calculating insulin needs is real.”
“Having an automated system to remove some of that calculation could really increase accuracy,” she noted, “and reduce the risk of adverse outcomes from overdosing on insulin [which leads to hypoglycemia] or chronic underdosing – poorly controlled [diabetes] it leads to all kinds 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 the insulin pump equipment. However, importantly, the incidence of severe hypoglycemia was not statistically different between the two groups.
However, the number of events of mild hypoglycemia, or low blood glucose, was low and did not differ between groups.
Dr. Raskin noted that “there have been problems with patients using the device. First there were some difficulties in filling the syringes with insulin. Some patients were impatient because the pump delivered insulin around meals more slowly than a patient could do using a syringe.”
Because it is a new technology, the researchers expect that additional testing of the bionic pancreas will be necessary. Patients will need support in using the device and healthcare professionals will need training.
dr. Lansen asked an important question MNTraising the question of whether the findings of this trial are broadly applicable.
“Patients enrolled in the study started with a fairly tight A1c (7.7%) [glycated hemoglobin] and they had already been on insulin for a year,” said Dr. Lansen.
“I would be interested to see how patients would respond to the bionic pancreas if they started in a state of much poorer glucose control.” Separately, I wonder why the control group in this study did not yield. We would expect at least a small drop in A1c over 13 weeks in the standard care group,” she noted.
Prof. Joseph agreed, saying MNT that “there is still a way to ensure that the bionic pancreas is absolutely safe and secure. There were some patients in the study whose blood sugar kept rising because the cannula became blocked. But when you have technology that can alert you that your sugar level is rising, allowing you to intervene, put in a new cannula and get back on track, this can avoid these problems, so there will always be a degree of vigilance required.”
Overall, this research shows the promise of this new technology and its applications for patients. Further research is needed, but over time this technology may one day replace the current standard of care.
“The bionic pancreas is another step closer for type 1 diabetes patients to start living a life where they don’t have to be on hypervigilance checking their glucose and blood sugar all the time and worrying about the levels constantly fluctuating. Technology allows this to happen more easily, without the patient constantly thinking about their diabetes and, in turn; what they will eat, how much sugar is in their blood; how much insulin they should take, and stop injecting four times a day. That’s a big advantage.”
– prof. Frank Joseph
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