Medtronic, Inc. (NYSE:MDT) today announced it has received U.S. Food and
Drug Administration (FDA) approval for the MiniMed Paradigm® REAL-Time
Revel™ System, the next generation of the industry’s only integrated
diabetes management system (insulin pump therapy, continuous glucose
monitoring (CGM) and diabetes therapy management software). The system
incorporates new innovative 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.
“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.”
“Medtronic is extending its lead in the path towards the artificial
pancreas with this next generation integrated system and our ongoing
advancements in algorithm development,” said Katie Szyman, president of
the Diabetes business and senior vice president at Medtronic. “We are
excited to make these leading innovations available to improve patients’
lives with the industry’s only integrated system in the world today. 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.”
When using Medtronic’s 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. According to recent internal
study, the use of predictive alerts improved hypoglycemic event
detection by 36% compared to the standard low glucose alert.
All alerts can be customized to suit a patient’s lifestyle, such as
creating different settings to accommodate for exercise or to manage
nocturnal hypoglycemia.
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, now 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.
"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, M.D., professor of pediatrics and chief of pediatric
endocrinology at Yale University School of Medicine. "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."
There is a growing body of clinical evidence that continues to prove
that the more often patients use Personal CGM, the greater average
glucose control (A1C) they can achieve without increasing hypoglycemia,
including the JDRF-Funded Studies and REAL TREND Study.
Today, insulin pumps are covered by nearly all commercial and government
insurance programs in the United States, and nearly 90 percent of type 1
diabetes patients with commercial insurance coverage have access to CGM
when medical criteria is met. Personal CGM is approved for use by people
ages 7 and older in the United States.
Diabetes rates skyrocket globally with millions left untreated