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[IP] FDA Panel Gives Its Approval
here's the news!
FDA Panel Gives Its Approval
To MiniMed's Glucose Monitor
By OTESA MIDDLETON
Dow Jones Newswires
WASHINGTON -- A new type of glucose monitor by MiniMed Inc. won
the recommendation of a federal advisory panel, with certain conditions.
On Friday, the panel recommended the Food and Drug Administration
approve MiniMed's continuous glucose monitoring system, which could
dramatically improve how doctors care for diabetics. The FDA will make the
final decision on the device, although it usually clears drugs or devices
by its expert panels.
The monitor system includes a sensor, which is implanted just below the
and into the tissue of the patient's abdomen. The sensor checks glucose
five minutes and sends the information to a pager-like monitor.
After three days of gathering information, the patient returns to the
who will download the glucose information to a computer. The information
isn't displayed for the patient.
Dr. John Mastrototaro, MiniMed's senior director for sensor development
and manufacturing, said the monitor will help gather trends.
The monitor isn't meant to replace the regular finger-stick regimen, which
for diabetics to prick their finger to check blood sugar levels several
daily, Dr. Mastrototaro said.
"This will supplement standard glucose monitoring," Dr. Mastrototaro said,
because the monitor will provide 288 readings each day, compared with the
finger-stick, which is taken about every six hours.
Physicians can identify patterns, which could lead to modification of
he told the panel.
Dr. Todd Gross, MiniMed's manager of corporate statistics, told the panel
that the company's studies involved about 60 insulin-dependent patients
five to 10 sensors implanted in each patient, although for commercial use
one sensor at a time will be necessary.
During the total 1,153 days the sensors were used only seven mild to
moderate adverse events were reported. The side effects included
minor bleeding, bruising and discomfort, Dr. Gross said.
To complete the application MiniMed submitted to the FDA, the agency
asked the company to conduct a simulated patient study. For the simulation,
the sensor was placed in beakers with a glucose solution. The company
changed the sugar levels constantly and recorded the accuracy of the
"There was excellent agreement," Dr. Mastrototaro said. "It confirms the
sensor provides an accurate profile."
Dr. Alan Marcus, a MiniMed medical consultant and associate professor at
the University of Southern California, said the monitor system offers a
detailed look at a patient's sugar levels.
Dr. Marcus told the panel the monitor would be helpful occasionally to help
patients realize when their glucose levels are fluctuating widely. Also,
patients, the system could be used to help determine when they should check
their glucose with finger sticks.
The panel also heard the FDA's analysis of MiniMed's data. The device uses
"groundbreaking technology," said Dr. Steven I. Gutman, director of FDA's
Division of Clinical Laboratory Devices in the Office of Device Evaluation.
John Dawson, an FDA statistician, said in reviewing MiniMed's data, the
monitor's information agreed with other glucose readers 88% of the time.
Dr. Gerald Bernstein, president of the American Diabetes Association, said
device like MiniMed's could improve the standard of living for people with
diabetes. Because the monitor will help adjust therapy to better manage
patient's glucose levels, Dr. Bernstein said patients may function better.
"People whose glucose levels are better controlled have a better quality of
life," said Dr. Bernstein, who is also director of the diabetes management
program at Beth Israel in New York. "It could help prevent complications
help people function better."
If approved, Dr. Berstein said the first group of diabetics that will
benefit from MiniMed's monitor are the one million Americans with type 1
diabetes, who are insulin dependent.
As the technology advances, Dr. Bernstein projects use of the monitor will
increase when patients can use it read their glucose levels. "In its
its use is modestly limited," Dr. Bernstein said. "As it evolves, it will
possibly universal. Many people hate sticking their fingers," he said.
The FDA panel unanimously backed MiniMed's monitor system. All members
said additional studies were needed. However, group members disagreed on
whether more trials should be conducted before or after the device is
available on the market.
Panelist Dr. James Everett, medical director of the family medicine
department at Morehouse School of Medicine in Atlanta, said before the
monitor is approved, MiniMed should look at a more diverse group of
patients. Of the patient's MiniMed studied all were Caucasian, except for
three African-Americans and one Asian.
Panelist Dr. Steven Clement, director of the Georgetown Diabetes Center
here, agreed with Dr. Everett that additional groups need to be studied
to approval and he said gathering additional information should be helpful
Other panelists said additional studies on diabetic children and patients
other complications should be conducted after the product is on the market.
About 16 million people in the U.S. suffer from diabetes. Most American
diabetics have the type 2 form of the disease. Approximately one million
diabetics have type 1 diabetes, which causes them to rely on insulin.
Diabetes occurs when the body can't regulate its glucose. Patients
have elevated sugar levels resulting from decreased insulin, which is
by the pancreas.
ING Barings analyst Kevin Kotler said if the FDA agrees with the panel and
approves MiniMed's device, sales could reach $65 million by 2001. That
projection, Mr. Kotler said, assumes MiniMed would have the next
generation of the device on the market, which would allow patients to read
glucose levels using the system.
Kelly L. Shaughnessy
Merrill Lynch Fundamental Equity Research
(415) 274-8255 (fax)
Insulin Pumpers website http://www.insulin-pumpers.org/
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