March 17, 2010 - The FDA has approved Medtronic's new
diabetes management system, which takes patients one step closer to the
elusive goal of an artificial
The new MiniMed Paradigm REAL-Time Revel System does not entirely close the
loop between glucose monitoring and insulin treatment. Patients still have to
confirm the device's warning with a finger-stick blood sugar measurement.
But the monitor predicts dangerously low or high
blood sugar levels. And the pump allows patients to administer insulin in
very low increments -- as low as 1/40 of a unit per hour -- a useful
feature for children or other people who are sensitive to insulin.
Moreover, the system comes with a device that plugs into a computer's USB
port and wirelessly uploads information from the
insulin pump and glucose monitor. Web-based software helps patients keep
close track of their blood sugar control.
In a recent Medtronic study, the new system improved detection of
low-blood-sugar events by nearly 36%, while only very slightly decreasing (by
4%) detection of high-blood-sugar events.
In a Medtronic news release, William Tamborlane, MD, chief of pediatric
endocrinology at Yale Medical School, says that linking an insulin pump to a
continuous glucose monitor improves diabetes patients' blood sugar control
while reducing the risk of blood sugar crashes.
"Advances such as predictive alerts and smaller [insulin] 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 says the system is immediately available to patients.
The retail price of the system is $6,500, but Medtronic says some 90% of type 1
diabetes patients with commercial insurance coverage who have a medical
indication for the device will be reimbursed. A Medtronic spokesperson tells
WebMD that the out-of-pocket costs for such patients is between $500 and