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Re: [IP] closing the loop-check this out

At 02:26 AM 8/17/2002 -0400, you wrote:
>this is what i call documentation and progress...look out all you
>pessimists...proofs in the trials...  :) cheers, bassem

Ok, I still can't seem to keep my big mouth shut, so here it goes.  I will 
be gone this weekend to visit SSPAZ so this will be the last from me in a 
few days.  :-)

I DO NOT appreciate being called a pessimists with regards to this 
topic.  I am a realist.  I have lived with this disease for 40 years and 
cures were suppose to be out 33 years ago.  Then it was another five years, 
then another.  Well I am still waiting on the original first five years 
promised, and that's 33 years later.  Again I hope if for some reason it 
does come out then you will be more than happy to shake your finger and say 
I told you so.

I CANNOT believe anything I read for 40 years of experience have taught me 
that the media can put any spin on anything to make it look good.


>    Research Presented At ADA Annual Meeting Demonstrates Accuracy and
>Feasibility of Artificial Pancreas Components
>Investigational device mimics a pancreas, brings an artificial pancreas one
>step closer to reality
>SAN FRANCISCO - June 17, 2002 - An artificial pancreas has long been
>considered the Holy Grail of diabetes management, yet many people with
>diabetes and their physicians believe that it is decades away. However,
>Medtronic MiniMed, the diabetes management business of Medtronic, Inc. (NYSE:
>MDT), today announced results of research indicating that a medical device
>mimicking the human pancreas is closer to becoming a reality. The study,
>conducted by investigators at the Department of Endocrine Diseases,
>Lapeyronie Hospital in Montpellier, France, and sponsored by Medtronic
>MiniMed in Northridge, Calif., was presented during the annual meeting of the
>American Diabetes Association (ADA). Long-Term Sensor System Evaluated The
>study presented at the ADA annual meeting and conducted in France, "Accuracy
>of Real- Time Blood Glucose Measurement by Long-Term Sensor System Allows
>Automated Insulin Delivery in Diabetic Patients," was designed to assess the
>sensor accuracy over a six-month period and to test automated insulin
>delivery according to the sensor's signal. Five Type 1 diabetes patients were
>implanted with a long-term glucose sensor and an implantable insulin pump,
>which together comprise Medtronic MiniMed's Long-Term Sensor Systemb". In
>system, an implantable sensor, which measures glucose levels using an
>enzyme-based electrochemical technology, was inserted in the bloodstream near
>the right atrium of the heart. An abdominal lead was used to connect the
>implantable sensor to a Medtronic MiniMed Model 2007 implantable pump, which
>can be programmed to deliver insulin to a patient using a hand-held remote
>programmer. At weekly intervals during the six-month study, glucose readings
>taken by the implantable sensors were compared with the results of at least
>six daily capillary blood glucose (CBG) measurements, more commonly known as
>"finger stick" tests. Cumulative data from the implantable sensors strongly
>correlated with the CBG results, with an r-value of 0.83 to 0.93. The closer
>the r-value is to 1.0, the higher the direct correlation is between the
>device and the results measured in blood sugars. Over a two-day period,
>investigators also tested the system in a "closed-loop" setting, in which
>continuous glucose data from the sensor was used to automatically regulate
>insulin delivery from the implantable pump. In this system, the amount of
>insulin required to manage a patient's diabetes is calculated using a
>mathematical algorithm. The researchers found that glucose levels of patients
>using the implantable sensor were maintained in a near-normal range (70 to
>120 mg/dL) more often (42.3 percent of the time) than patients whose insulin
>requirements were determined by CBG measurements (21.6 percent of the
>time)."We are extremely pleased with the accuracy of the implantable sensor
>over the course of the study, and the promising results of our closed-loop
>trial," said Eric Renard, M.D., Ph.D., lead investigator of the study and
>Professor of Endocrinology, Diabetes and Metabolism, Montpellier Medical
>School, Montpellier I University; Senior Medical Practitioner, Department of
>Endocrine Diseases of Lapeyronie Hospital in Montpellier, France. "In using a
>sensor-augmented system, we are essentially creating an artificial pancreas.
>This type of system is intended to help people who are unable to control
>their diabetes despite intensive insulin therapy." "While implantable sensors
>are still being tested, Medtronic MiniMed's Continuous Glucose Monitoring
>System, which uses an external sensor, is being used today by clinicians for
>improved diabetes management," added Alan Marcus, M.D., F.A.C.P., associate
>clinical professor, University of Southern California Keck School of
>Medicine, who has extensively studied and authored many articles using the
>system. "The external sensor, which is generally worn by a patient for up to
>three days, can provide up to 288 glucose values retrospectively over a
>24-hour period, and offers far more comprehensive information than nominal
>glucose measurements obtained by patients using traditional strips and
>Latest Closed-Loop Results In the fourth and most recent closed-loop
>experiment, the company combined an algorithm for calculating insulin
>requirements with a pre-meal bolus (extra insulin delivered by the
>implantable pump) to address high blood sugar that is normally associated
>with meal consumption. By delivering a pre-meal bolus, the magnitude and
>duration of post-meal hyperglycemia (high blood sugar) were greatly reduced
>without increasing hypoglycemia (low blood sugar). In diabetes patients,
>hypoglycemia can occur when a patient attempts to lower elevated blood sugars
>by delivering extra insulin. Over a 24-hour period, hypoglycemia was reduced
>by more than 50 percent. Moreover, the patient spent nearly 50 percent more
>time between 70 and 120 mg/dl (the study's stringent target range), resulting
>in overall improved glycemic control. "We are delighted with the positive
>results of this fourth closed-loop study using our Long-Term Sensor System,"
>said Scott R. Ward, Senior Corporate Vice President and President, Medtronic
>Neurological and Diabetes. "Medtronic MiniMed has a vast amount of experience
>in conducting closed-loop studies, and we continue to refine our algorithms
>to further strengthen our knowledge of glycemic control. Our product pipeline
>includes advanced algorithms that work with both external and implantable
>sensors and insulin pumps. We are committed to developing an artificial
>pancreas, in which a system continuously records glucose and delivers insulin
>automatically, without the patient intervention that is necessary today."
>Medtronic MiniMed (<A HREF="http://www.minimed.com/">www.minimed.com</A>)
>designs, develops, manufactures and
>markets advanced infusion systems with a primary emphasis on the intensive
>management of diabetes. The company's products include external pumps and
>related disposables; a continuous glucose monitoring system; an implantable
>insulin pump, which currently is approved for distribution in the European
>Union, and is under clinical investigation in the United States; and an
>implantable sensor, which is in clinical trials prior to FDA submission.
>Medtronic, Inc. <A
>/A>), headquartered in
>Minneapolis, is the world's leading medical technology company, providing
>lifelong solutions for people with chronic disease. More information about
>pump therapy and continuous glucose monitoring is available online at <A
>www.medtronic.com/newsroom/media_kits_Diabetes.html</A>. - 0 -
>For a brief statement about the use of the CGMS system, please <A
>indications.pdf">click here</A>.
>EDITOR'S NOTE: Detailed information about diabetes, insulin pump therapy,
>continuous glucose monitoring devices and the Paradigm pump is available by
>accessing Medtronic's online newsroom at <A
>Any statements made about the company's anticipated regulatory approvals are
>forward-looking statements subject to risks and uncertainties such as those
>described in the company's Annual Report on Form 10-K for the year ended
>April 27, 2001. Actual results may differ materially from anticipated
>Components of the artificial pancreas, including the implantable pump and the
>implantable sensor or long-term sensor system, mentioned in this document are
>intended for investigational use only and have not been reviewed for safety
>and efficacy by the U.S. Food and Drug Administration
>Kevin Lee, Investor Relations, 763-505-2695
>Deanne McLaughlin, Medtronic MiniMed, 818-576-4325
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