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Medtronic Receives FDA Approval For New Diabetes Management System

Medtronic has received FDA approval for MiniMed Paradigm REAL-Time Revel System, an integrated diabetes management system (insulin pump therapy, continuous glucose monitoring (CGM) and diabetes therapy management software). The system incorporates new CGM features including predictive alerts that can give early warning to people with diabetes so they can take action to prevent dangerous high or low glucose events.

Medtronic said that when using its glucose sensors with Paradigm Revel Insulin Pumps, trend alerts can notify patients of rapid changes in glucose levels so that they can take immediate corrective or preventative action after confirming glucose levels with a fingerstick glucose measurement. Several new CGM features, including predictive and rate of change alerts, provide earlier warnings of potential glycemic excursions to help patients stay in their target range.

New features in the insulin pump enable patients to tailor insulin delivery to meet their personal needs. Patients who are sensitive to insulin, such as children with diabetes, have the opportunity to deliver insulin in smaller increments (0.025 units per hour). In addition, insulin-using type 2 patients, who are often more insulin resistant, can more tightly control their glucose levels using the new 1:1 carbohydrate ratio. The system also enables patients to set up missed meal bolus reminders.

The MiniMed Paradigm REAL-Time Revel System is comprised of three key components: a ‘smart’ insulin pump, CGM and CareLink Therapy Management Software. CareLink software is a free online tool that helps diabetes patients and their healthcare providers analyze therapy and make adjustments through easy-to-read reports, charts and graphs.

Katie Szyman, president of diabetes business and senior vice president at Medtronic, said: “Medtronic is extending its lead in the path towards the artificial pancreas with this integrated system and our ongoing advancements in algorithm development.

“We are excited to make these innovations available to improve patients’ lives with the industry’s integrated system in the world. The MiniMed Paradigm Revel System can help a patient feel more secure by giving early warning of one of their greatest concerns, hypoglycemia, while continuing to simplify the complexity of diabetes management with easy-to-use features.”

William Tamborlane, professor of pediatrics and chief of pediatric endocrinology at Yale University School of Medicine, said: “Recent clinical evidence clearly supports that insulin pump therapy combined with continuous glucose monitoring improves patients’ A1C while reducing the relative risk of severe hypoglycemia. Advances such as predictive alerts and smaller basal delivery rates can help physicians and patients customize therapy to meet individual needs. This simplifies some of the complexity of daily diabetes management.”