Diabetes: Medtronic touts JAMA study of closed-loop artificial pancreas

Medtronic (NYSE:MDT) said data from a study of its closed-loop hybrid artificial pancreas, published in the Journal of the American Medical Assn., showed that the system is safe and effectively maintained blood glucose levels within range in Type I diabetes patients age 14 and older. Results from the 3-month, 124-patient trial, also presented this week at the annual meeting of the European Assn. for the Study of Diabetes in Munich, had safety endpoints of the incidence of severe hypoglycemia and diabetic ketoacidosis, serious adverse events and device-related serious and unanticipated adverse events. Data from the study was 1st presented in June at the American Diabetes Assn.’s annual meeting. The artificial pancreas system is designed to use Medtronic’s MiniMed 670G insulin pump, 4th-generation sensors and a control algorithm to automate basal insulin delivery to keep glucose levels in a healthy range as much as possible, 24 hours a day. Efficacy endpoints in the study included time in open vs. closed-loop systems; the percentage of sensor glucose values below, within, and above target range (71-180 mg/dL), including at night; changes in HbA1c, insulin requirements and body weight; and measures of glycemic variability. On the safety front, there were no episodes of severe hypoglycemia or ketoacidosis over the trial’s 12,389 patient-day span, according to the JAMA report. There were 28 device-related adverse events that were resolved at home; non-device...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Diabetes Artificial pancreas Journal of the American Medical Assn. (JAMA) Medtronic Source Type: news