From Medscape Medical News > Alerts, Approvals and Safety Changes > FDA Approvals
Laurie Barclay, MD
March 18, 2010 — The US Food and Drug Administration (FDA) yesterday approved Medtronic's MiniMed Paradigm REAL-Time Revel System, a diabetes management system that combines an insulin pump with a glucose monitoring system. The system may represent the next step toward an artificial pancreas.
"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," said Katie Szyman, president of the diabetes business and senior vice president at Medtronic, in a company news release.
The system includes "smart" insulin pump therapy and continuous glucose monitoring with predictive alerts that can give early warning of impending hypoglycemia or hyperglycemia. These alerts allow people with diabetes to intervene with appropriate action to prevent dangerous high or low glucose events.
In addition, the system includes online therapy management software that helps patients with diabetes and their healthcare providers evaluate and manage treatment and make needed adjustments based on easy-to-read reports, charts, and graphs.
Trend alerts detected by the system's glucose sensors can notify patients of rapid changes in glucose levels, which they need to confirm with a fingerstick glucose measurement and then take immediate corrective or preventative action, if needed.
Predictive and rate-of-change alerts, as well as other new features, help achieve optimal glucose target range by giving earlier warnings of potential glycemic excursions. These alerts can be tailored as appropriate for a specific patient's lifestyle; for example, by creating different settings for exercise or for management of nocturnal hypoglycemia. Compared with the standard low-glucose alert, the use of predictive alerts improved detection of hypoglycemic events by 36%, based on findings from a recent Medtronic study.
Similarly, insulin delivery can be customized to specific needs because of new features in the insulin pump. Children or other patients who are sensitive to insulin can now receive insulin in smaller increments (0.025 units per hour), and insulin-resistant patients with type 2 diabetes can more tightly control their glucose levels using the new 1:1 carbohydrate ratio. The system also allows for missed meal bolus reminders.
The Juvenile Diabetes Research Foundation International–funded studies and REAL Trend study, as well as other evidence, suggests that increased use of personal continuous glucose monitoring is associated with better average glucose control, as reflected in A1C, without increased hypoglycemic events. Nearly all US private and government insurance programs cover the costs of insulin pumps, and nearly 90% of type 1 diabetes patients with private insurance are covered for continuous glucose monitoring costs, provided they meet medical criteria. In the United States, personal continuous glucose monitoring is approved for use by people at least 7 years of age.
"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," said William Tamborlane, MD, professor of pediatrics and chief of pediatric endocrinology at Yale University School of Medicine in New Haven, Connecticut, in a company news release.
"Advances such as predictive alerts and smaller basal delivery rates can help physicians and patients customize therapy to meet individual needs. This ultimately simplifies some of the complexity of daily diabetes management," Dr. Tamborlane said.
The system is immediately available, Medtronic said.
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