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 The U.S. Food and Drug Administration, in its approval of the
device, the MiniMed 670G, hailed it as a breakthrough.
The device offers type 1 diabetics "greater freedom to live their
lives without having to consistently and manually monitor baseline
glucose levels and administer insulin," Dr. Jeffrey Shuren, director
of the FDA's medical device division, said in a statement.
Analysts said the FDA approved the device six months sooner than
expected. However, it will not be available until the spring of
2017.
The MiniMed 670G is the first device that allows a glucose sensor to
communicate with an insulin pump and automatically regulate the
insulin flow. The device is approved for those aged 14 and older.
The device measures glucose levels every five minutes and
automatically administers insulin as needed. Patients will still
need to instruct the device to deliver extra insulin for meals and
notify the device when they exercise - which lowers glucose levels.
About 1.25 million American children and adults have type 1
diabetes, a condition in which the pancreas produces little or no
insulin - a hormone needed to obtain energy from food.
Patients take insulin injections at various times of the day. But
blood sugar can drop to dangerously low levels if too much insulin
circulates in the bloodstream, requiring patients to frequently or
continually monitor their insulin levels throughout the entire day.
"This device will mean peace of mind, in knowing a person will be in
normal blood sugar range a great majority of the time," said Derek
Rapp, chief executive officer of the Juvenile Diabetes Research
Foundation, which has spent $116 million on research in the
artificial pancreas field.
Rapp, who has a college-age son with type 1 diabetes, said his son
as a child had to be awakened many times each evening so his finger
could be pricked for a blood sample, to ensure his blood sugar level
was in an acceptable range. If too low, his son would be given fruit
juice or a snack. If too high, he would be given insulin.
"It is a major news event that a system of this kind has been
approved - the first time a pump will administer insulin as a result
of information it receives from a sensor," Rapp said.
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The Medtronic device includes a coin-size sensor with a protruding
needle that is slipped under the skin and continually monitors
glucose levels. It is held in place with a sticky backing. The other
main component is an insulin pump, often worn on the side of the
abdomen, which has tubes that lead to a catheter that delivers the
insulin.
Insulin pumps are currently used by more than a third of U.S.
patients with type 1 diabetes, but they require manual adjustment to
administer the needed insulin dose. Many patients also wear sensors
that continually monitor their glucose levels.
Several insulin pump makers, including Johnson & Johnson , Tandem
Diabetes Care Inc and Insulet Corp, are teaming up with sensor maker
Dexcom Inc to develop devices like Medtronic's but are several years
behind, according to Jefferies analyst Raj Denhoy.
He said the Medtronic system is a big step for patients, but the
Holy Grail would be a completely automatic artificial pancreas that
does not need any intervention, including for meals or exercise.
Such a product is probably at least five years away from
development, he said.
Although Medtronic has not announced a price for the MiniMed 670G,
Denhoy estimated it may cost $5,000 to $8,000, with the annual cost
of disposable sensors another few thousand dollars.
(Editing by Bernard Orr and Leslie Adler)
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