The Artificial Pancreas Still A Long Ways Ahead

by Mark Benson on November 11, 2011

Artificial pancreas now being tested in US

Medtronic’s artificial pancreas is set to undergo its first US clinical trial under the auspices of the Food and Drug Administration. Despite this groundbreaking trial, the United States still remains lagging behind in providing this glucose delivery system to its diabetic population.

The ideal design of the artificial pancreas is a small, portable, easily accessible and disguisable closed-loop system of a continuous glucose monitor, an insulin pump able to provide precise amounts of insulin and a program that guides the pump to deliver the needed insulin according to the current blood sugar levels of the diabetic.

Aside from Medtronic, other companies such as Dexcom, Abbott and others have already provided continuous monitors that alert users of dangerous blood sugar levels. The clinical trial of Medtronic would use its Enlite sensor, whose design claims to provide painless sensor attachment and accurate blood sugar level readings. The other companies throwing their hat into the artificial pancreas ring are Animas, Roche and Insulet, aside from Medtronic.

These technologies though are still not stand-alone systems according to the FDA. They still need to be used in conjunction with finger sticks. These systems also are quite expensive and need to be maintained properly. According to the JDRF’s Dr. Aaron Kowalski, current vice president for treatment therapies, “In the near term, the pieces absolutely exist. At least the way I see it, the technology exists today to partially close the loop. We need to add some degree of automation, so there are some technological advances that need to happen.”

The nearest current technology to an actual artificial pancreas is the MiniMed Paradigm REAL-Time REVEL System. This system has an insulin pump, a continuous glucose monitor and personal therapy management software. This is the US design while in Europe, the Medtronic Paradigm Veo is already available. The Veo design has a more advanced design that uses low glucose suspense system, stopping the pump from delivering insulin for two hours when blood glucose levels are too low. The Veo though is not available in the US.

Other studies are also going on to make the artificial pancreas a reality. The Mayo Clinic has been running trials on a closed loop system using an abdominal patch to measure blood sugar levels and a small pump to deliver the insulin together with a software algorithm utilizing the patient’s information. This Mayo Clinic trial also accounts for physical activity and metabolic response, a critical variable to insulin sensitivity. Similarly, the Massachusetts General Hospital is also in phase 2 clinical trials on an artificial pancreas system using a continuous glucose monitor, two pumps attached to a laptop. The researchers are aiming to replace the laptop with a computer chip to make the full system the size of a mobile phone. This study has a unique characteristic as it includes glucagon, a hormone that protects the body from hypoglycemia to raise blood sugar levels when too much insulin is present.

For the millions of diabetes sufferers in the United States, they are awaiting with bated breath on the approval of the FDA for the technology that can help them manage a debilitating condition to help them lead normal lives for their future.

The opinions expressed in this article do not necessarily reflect the views of the Community and should not be interpreted as medical advice. Please see your doctor before making any changes to your diabetes management plan.

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