When it comes to the artificial pancreas, the question on the minds of endocrinologists and patients alike is “Why is it taking so long?”
Ron Brazg, MD, FACE, principal investigator at Rainier Clinical Research Center, Renton, Washington, addressed the progress made in the development of the artificial pancreas during his lecture, “Advance Towards the Bionic Pancreas,” part of Wednesday’s “Diabetes Technology 2016” seminar.
Given the benefits of a closed-loop system or artificial pancreas, getting FDA approval of a system is a top priority, said Dr. Brazg.
“The FDA specified that this is a system, which means you have to have the whole system intact to study it and get approval. This includes the blood glucose monitor, the CGM device, the pump, and the algorithm,” Dr. Brazg said. “The only thing that differentiates what’s currently available from an artificial pancreas is the algorithm software within the pump and the type of pump that will be used.”
He began with a historical look at when the various pieces of the artificial pancreas became available. While the first blood glucose meter became available in 1970, continuous glucose monitoring has only been available since 2004 — meaning researchers have only had all the pieces of the puzzle for 12 years.
In that time, much has been accomplished toward developing a safe, effective system. As part of his talk, Dr. Brazg reviewed the research that has been done on the accuracy of blood glucose monitors and continuous glucose sensors.
He reviewed data showing historical problems with some monitors that fail to meet accuracy criteria. However, he also said advances have now given endocrinologists extremely accurate meters that are capable of running an artificial pancreas.
Dr. Brazg then reviewed data on the current status of continuous glucose monitors. Newer CGM devices have also reached the point where they are reliable enough for use in a closed-looped system, and the first implantable glucose sensor was recently approved for use in Europe, he said.
Dr. Brazg reviewed a study published in Diabetes Care last month, which looked at 30 patients with Type 1 diabetes using a hybrid closed-loop system, which showed improvements in blood glucose control in just one week and further improvements at four weeks. Before using the system, the patients had an average glucose of 191 mg/dl. At one week the average was 146 mg/dl and at four weeks it was 131 mg/dl.
“You can see, in a closed-loop system, there was a significant reduction – from 4.1% to 1.7% – blood glucose levels less than 70 mg/dl,” Dr. Brazg said. “Time in range went from 64% to 73%. Time above range went from 32% down to 25%. All of those parameters were met in a short time.”
The seminar also included lectures on insulin pump therapy and continuous glucose monitoring, meter, pump and sensor downloads, early clinical experience in automated predictive low glucose management, and the role of diabetes technologies in advancing diabetes care.