Harvard University and the University of Virginia are teaming up to conduct clinical trials on a new artificial pancreas that could improve the quality of life for type 1 diabetes patients.
The two parts of the study have 420 patients participating in total. If these trials are successful, the next step will be commercial trials of the system, followed by a quest for regulatory approval from the Food and Drug Administration to make the artificial pancreas available to all people with diabetes.
In the first part of the study, 240 patients will use the artificial pancreas in addition to their insulin pumps to see how their daily lives are affected.
Researchers will measure the patients’ glucose levels to test the safety and reliability of the artificial pancreas. The second part of the study will give the artificial pancreas system to another 180 patients in an effort to try out a different algorithm for controlling insulin levels.
The artificial pancreas works like a smartphone app to contact the user’s insulin pump and measure out tiny doses of insulin in response to minute-by-minute changes in the patient’s body. In this way, it attempts to make the insulin pump work just like the human pancreas, which dispenses insulin not on a regular schedule, but depending on a person’s blood sugar, stress, and hormone levels.
One of the early patients in the clinical trial found that the artificial pancreas let him stop thinking about his diabetes, whereas previously it was always in the back of his mind as he constantly calculated how his blood sugar was doing and whether he needed to eat something. The patient commented that he can’t wait to be able to turn his Type 1 diabetes over to an artificial pancreas fully.The clinical trials of the artificial pancreas at Harvard and the University of Virginia are just one step toward a cure for diabetes. Any medical device like the artificial pancreas must be approved by the U.S. Food and Drug Administration before the general population has access to it.
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