A new short-term trial finds the bionic pancreas manages blood sugar levels in people with type 1 diabetes better than sensor-augmented insulin pump therapy.
This 11-day study was conducted by Massachusetts General Hospital (MGH) and investigated the bionic pancreas in a home setting. The participants had no restrictions on diet and exercise and were free to pursue normal activities at home or at work.
“For study participants living at home without limitations on their activity and diet, the bionic pancreas successfully reduced average blood glucose, while at the same time decreasing the risk of hypoglycemia,” said Steven Russell, MD, PhD, of the MGH Diabetes Unit.
The bionic pancreas system is the brainchild of Edward Damiano, PhD and colleagues at Boston University. Their device is known as the iLet, which manages both insulin and glucagon treatment in people with diabetes; an algorithm then makes therapeutic decisions every five minutes to determine how much treatment is needed.
The device has already shown to be successful in managing type 1 diabetes during multiple outpatient clinical trials, and Damiano’s goal is to have an insulin-only version of the iLet approved by the US Food and Drug Administration (FDA) in 2018.
The 39 participants in this new trial had been diagnosed with type 1 diabetes for a year or more and been using an insulin pump for at least six months. They all completed two 11-day study periods: one using the bionic pancreas, and the other using their normal treatment.
When patients used the bionic pancreas, their average blood sugar levels were 7.8 mmol/l compared to 9 mmol/l when on their standard treatment.
Russell added that the bionic pancreas reduced the risk of overnight hypoglycemia to “almost nothing without raising the average glucose level”. The improvement in overnight blood glucose levels was even greater than the average across the full 24-hour period.
Highlighting the easy accessibility of the device, Russell said: “This system requires no information other than the patient’s body weight to start, so it will require much less time and effort by health care providers to initiate treatment.
“And since no carbohydrate counting is required, it significantly reduces the burden on patients associated with diabetes management.”
The findings of this study have received advance online publication in The Lancet.
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