Comments by Lead Investigator: Moshe Phillip, MD
Medtronic will be responsible for developing and marketing any devices that use the GlucoSitter technology, which is based on the MD-Logic Artificial Pancreas algorithm, an automated system for controlling glucose levels. DreaMed, which is based in Israel, will receive an undisclosed amount of royalties from future sales and will retain ownership of the algorithm.
GlucoSitter is a wireless fully automated closed-loop system that can be used with an insulin pump or can be operated on a dedicated hand-held device. It uses an algorithm based on fuzzy logic theory, a learning algorithm, and an alerts module and personalized system setting. By analyzing blood glucose levels and directing an insulin pump to deliver correct doses of insulin to the body, the system minimizes the risks of hypo- or hyperglycemic events.
Moshe Phillip, MD, Chief Scientific Officer of DreaMed Diabetes and Director of the Institute for Endocrinology and Diabetes at Schneider Children’s Medical Center of Israel, notes that the MD-Logic Artificial Pancreas is based on work by researchers in Israel, Slovenia, and Germany. Speaking of the MD-Logic system, he said, “It has the ability to communicate with the patient, with the environment, with the physicians and with the family if needed.”
Dr. Phillip and his colleagues conducted a multicenter randomized crossover trial on 56 young patients with type 1 diabetes at three diabetes camps in three countries. They compared overnight use of DreaMed’s artificial pancreas technology to a sensor-augmented insulin pump. The campers had been using insulin pumps for at least three months. The study found that the campers, aged 10 to 18, had tighter glucose control on the nights they used the artificial pancreas. They experienced significantly fewer (P=0.003) episodes of nighttime hypoglycemia and significantly shorter (P=0.02) periods of time when glucose levels dropped below 60 mg/dL compared to nights when they used the sensor-augmented insulin pump. The number of episodes of blood glucose dropping below 63 mg/dL was 7 with the artificial pancreas compared to 22 with the sensor-augmented insulin pump.1
Home Use Evaluated
The GlucoSitter closed-loop system has also been used by people with diabetes in their homes for more than 850 nights, according to Dr. Phillip. An interim analysis has shown that the number of hypoglycemic events and the amount of time spent in hypoglycemia can be reduced, he said. “We can keep the blood glucose level most of the time in the desired range.”
Diabetes is Medtronic’s fifth-largest business unit, according to the company’s website. The company offers an integrated diabetes management system approved by the US Food and Drug Administration that includes an insulin pump, a continuous glucose monitor, and software to manage the system. "We believe that a fully automated artificial pancreas will provide greater freedom and better health for many people with diabetes by eliminating some of the burden of glucose management," said Alejandro Galindo, Vice President and General Manager of the intensive insulin management business at Medtronic.
1. Phillip M, Battelino T, Atlas E, et al.: Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med. 2013; 368:824-33.