FDA Approves Medtronic's New Automated Insulin Pump
September 28 2016 - 4:42PM
Dow Jones News
By Ezequiel Minaya
The U.S. Food and Drug Administration said Wednesday it has
approved an insulin pump by medical device company Medtronic PLC
that automatically manages glucose levels within a target
range.
The device, known as the MiniMed 670G, is designed to work with
less monitoring from patients, compared with previous models that
called for more vigilance.
Insulin works to lower blood sugar, but it also can cause sugar
levels to fall too low. The condition, called hypoglycemia, can be
fatal, especially at night when patients aren't aware their blood
sugar is low.
The MiniMed 670G "works by measuring glucose levels every five
minutes and automatically administering or withholding insulin,"
the FDA said in a prepared statement. The system includes a sensor
that attaches to the body to measure glucose levels under the skin;
an insulin pump strapped to the body; and an infusion patch
connected to the pump with a catheter that delivers insulin.
A Medtronic spokeswoman said the MiniMed 670G would have similar
pricing to models already in the market, though further details
weren't immediately available, she said.
The FDA evaluated data from a clinical trial of the device that
included 123 participants with Type 1 diabetes. The agency added
that while the device is being approved for use in people 14 years
of age and older with Type 1 diabetes, Medtronic is currently
performing clinical studies to evaluate the device for use by
diabetic children seven to 13 years old.
Blood-sugar sensors have been available to help diabetics
program pumps to deliver the proper amount of insulin. Researchers
have been working for years to link the two technologies to
automate insulin delivery as part of an effort often referred to as
an artificial pancreas.
The MiniMed 670G "is designed to learn what an individual's
insulin needs are and to take action to minimize both high and low
glucose levels," Medtronic said in a news release. As a result,
Medtronic said, the system requires minimal input -- patients only
need to enter mealtime carbohydrates, accept bolus correction
recommendations and periodically calibrate the sensor.
Shares of the company edged up 0.1% to $86.74 in afternoon
trading in New York.
The device is geared toward patients with Type 1 diabetes,
commonly known as juvenile diabetes, though the disease can occur
at any age. Type 1 diabetes is triggered when the cells that
produce the hormone insulin in the pancreas are destroyed. Patients
with Type 1 diabetes must have insulin delivered by injection or
pump.
According to the National Diabetes Statistics report of 2014,
put out by the U.S. Centers for Disease Control and Prevention,
Type 1 diabetes accounts for about 5% of all diagnosed cases of
diabetes in adults.
Write to Ezequiel Minaya at ezequiel.minaya@wsj.com
(END) Dow Jones Newswires
September 28, 2016 16:27 ET (20:27 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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