Medical device titan Medtronic (NYSE:MDT) touted positive results for its MiniMed mechanical insulin pump system, which the company calls the 1st iteration in the development of a fully automated artificial pancreas.
The device features "threshold suspension," a program which monitors and modifies insulin delivery when blood glucose readings hit preset levels, helping reduce the incidence of hypoglycemia without affecting blood sugar. In a clinical trial of nearly 250 patients with Type I diabetes and nocturnal hypoglycemia, researchers reported that acute events were 31.8% less likely in patients using the device with threshold suspension.
Medtronic and other medical device makers are racing to develop the 1st true artificial pancreas systems, which could monitor blood glucose and deliver insulin with little intervention from the patient or care-giver.
"The study results are important as we continue to move toward our goal of developing a fully automated system, or artificial pancreas, that will one day require very minimal interaction from the patient," said Dr. Francine Kaufman, Medtronic’s VP of medical affairs, diabetes, in prepared remarks.
Medtronic has also begun enrolling patients in a U.S. study to evaluate a new close-looped algorithm for night-time glucose management. The FDA is classifying this as a so-called control-to-target system, or a system that doesn’t need to be managed by the patient. Medtronic called this trail a key feasibility test for its 3rd generation artificial pancreas.
The company initially filed a bid for FDA approval of its MiniMedR 530G system in June 2012. The recently published trial was an at-home patient study under investigational device exemption from the FDA.
