Medtronic receives FDA approval for insulin pump with glucose monitoring
23 April 2006
Minneaplosi, USA. Medtronic, Inc. (NYSE:MDT) has received FDA approval of
the MiniMed Paradigm real-time insulin pump and continuous glucose
monitoring system, a progressive new therapy available for patients who use
insulin to treat diabetes.
For the first time in the history of diabetes management, an insulin pump
integrates with real-time continuous glucose monitoring (CGM). This new
technology will help patients take immediate corrective or preventive action
to maintain healthy glucose levels and delay or prevent diabetes-related
complications, including coma, blindness, kidney failure, amputation,
impotence, and heart disease.
The system is made up of two components, a real-time continuous glucose
monitoring (CGM) system and a MiniMed Paradigm insulin pump. The CGM System
relays glucose readings every five minutes from a glucose sensor to the
insulin pump, which displays to 288 readings a day — nearly 100 times more
information than three daily fingersticks. Glucose information displayed on
the insulin pump allows patients to take immediate action to improve their
glucose control after taking a confirmatory fingerstick. The REAL-Time CGM
System component is indicated for any patient 18 years of age or older, and
insulin pump therapy for all patients requiring insulin.
"The approval of the MiniMed Paradigm REAL-Time System opens the door to
the next generation of diabetes management," said Robert Guezuraga,
president, Medtronic Diabetes. "As this is the first integrated insulin pump
and continuous glucose monitoring system ever approved, we feel this new
therapy will revolutionize the way patients manage their diabetes and will
improve their lives."
Integrating an insulin pump with REAL-Time CGM is a major step toward the
development of a "closed-loop" insulin delivery system that may one day
mimic some functions of the human pancreas. Medtronic is testing future
systems that would employ advanced scientific algorithms to proactively
recommend insulin dosages to patients. Through this process, Medtronic
anticipates developing an external, closed-loop system designed to simplify
and improve patient diabetes management.
The system's continuous glucose sensor is a tiny electrode that is
inserted under the skin using the Sen-Serter, a small device that patients
or their caregivers can use at home to make sensor insertion easier. The
sensor measures glucose in the interstitial fluid found between the body's
cells, and is typically discarded and replaced after three days of use.
Glucose measurements obtained by the sensor are relayed every five minutes
from a transmitter to the insulin pump, which displays the glucose value,
three-hour and 24-hour trend graphs, as well as arrows to indicate how
quickly glucose is moving up or down. In addition, an alarm alerts patients
when glucose levels become too high or too low.
The MiniMed Paradigm REAL-Time System includes a "smart" MiniMed Paradigm
insulin pump, which has a powerful built-in Bolus Wizard calculator to
manage the complex diabetes math for patients. Smart insulin pumps recommend
insulin dosages after considering the amount of insulin still "active" in
the body, helping patients avoid dangerous hypoglycemic episodes caused when
too much insulin is delivered.
Current standards for assessing glucose control include A1C tests and
fingerstick measurements, yet both have limitations. An A1C test, which
measures glucose control over a three-month period, is important for
long-term management, but it is only an average and does not reveal
day-to-day glucose fluctuations that can damage the body. In turn,
fingerstick measurements only reveal a glucose value at a single moment in
time. As a result, patients are unable to detect approximately 60 percent of
low glucose (hypoglycemia) events, and have difficulty assessing glucose
fluctuations while they sleep. In contrast, REAL-Time CGM allows patients to
view glucose trends throughout the day and night, and understand how fast,
and in what direction, their glucose levels are heading. By discovering how
diet, exercise, medication and lifestyle affect their glucose levels,
patients can make more informed self-management decisions and achieve a
greater sense of confidence when managing their disease.
Insulin pump therapy
An insulin pump is a small pager-size device that delivers insulin around
the clock, much like a healthy pancreas. It is the most advanced method for
precise and adjustable insulin delivery. Unlike injection therapy, insulin
pump users can program their insulin pump to deliver insulin at varying
rates to meet their changing insulin needs throughout the day and night. In
addition, insulin can be delivered on demand at the touch of a few buttons.
Many patients experience improved quality of life with insulin pump therapy,
ridding themselves of multiple injections, strict meal schedules and rigid
sleep patterns that are associated with injection therapy.
According to the American Diabetes Association, almost 21 million
Americans (7% of the population) have the disease. Diabetes affects children
and adults, costing the United States more than $132 billion in direct and