Some diabetics will no longer have to add up how much insulin they need for every bite of food. The Food and Drug Administration on Monday approved the first device that checks a patient’s blood sugar, automatically calculates how much insulin they need and signals an implanted pump to send out the right dose.
The paradigm system is a first step toward developing an artificial pancreas.
Diabetes specialists hope the new device will cut down on dosing errors and make it easier for patients to manage their disease.
“The smarter these systems can become ... the better our patients ought to be able to do,” said American Diabetes Association past president Francine Kaufman, a pediatric endocrinologist at Children’s Hospital of Los Angeles.
Diabetes is a leading cause of blindness, kidney failure and amputations, and dramatically raises the risk of heart attacks. It kills 180,000 Americans each year.
Some diabetics control their disease with diet, exercise and various medications; others require regular injections of insulin, a hormone crucial to converting blood sugar into energy.
More than 200,000 diabetics have insulin pumps implanted in their abdomens, a programmable system that can provide more precise, regular doses, infusing even while the patient is sleeping.
Patients still must figure out how much and when their pumps should emit by pricking their fingers to see how much glucose is in their blood and calculating how many carbohydrates they plan to eat. Calculating wrong could cause dangerously high or low doses.
The new system combines a Medtronic MiniMed Inc. insulin pump with a glucose monitor from Becton Dickinson to do a lot of that work automatically.
Patients still will prick their fingers, but the pager-sized monitor uses wireless technology to beam the glucose reading straight to the implanted insulin pump.
Once meal plans are punched in, a calculator in the pump will deliver a dose recommendation by calculating target glucose levels, the patient’s insulin sensitivity and how much insulin already is in the blood.
The patient still has final control, and may override the recommended dose.
Medtronic said the prescription-only device will begin shipping July 21 and cost $5,995, $500 more than Medtronic’s manually programmed insulin pump.
Shares in Medtronic rose 18 cents to $47.73 each on the New York Stock Exchange, where Becton Dickinson shares rose 24 cents to $39.75.