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Feasibility Study Demonstrates Positive Early Results Using Real-Time Glucose Readings to Improve Blood Sugar Control in Diabetic Children.

Business Editors/Health/Medical Writers

NORTHRIDGE, Calif.--(BUSINESS WIRE)--June 5, 2004

Medtronic, Inc. (NYSE:MDT) today announced the presentation of feasibility study results highlighting the potential benefits of "real-time" blood sugar (glucose) readings in children with type 1 diabetes using an external insulin pump and an external continuous glucose monitoring system. The findings were presented in a poster session at the annual meeting of the American Diabetes Association.

A particular advantage that pump users have compared to patients using injections is the flexibility to fine-tune and start or stop insulin delivery upon demand. Patients in the study used their pumps to make immediate therapy adjustments based upon real-time continuous glucose readings displayed every five minutes and by viewing a graph with 24-hour glucose trends. The prototype sensor-augmented system used in the study, which is not yet approved by the FDA, will be evaluated in a larger study later this year.

"Insulin pumps keep getting better and better," said Jennifer Caughman, parent of a 10-year-old study participant. "Participating in the study was a tremendous benefit to us because never before have we had real-time glucose readings to help us manage our son's disease. Being able to view glucose trends and see where his blood sugar levels were every five minutes was truly incredible. This information helped us make insulin adjustments with confidence and improve his blood sugar control."

Study Results

At the four-week evaluation point, 10 patients with type 1 diabetes between the ages of 10 and 18 (median age 14.5 years) showed trends toward improved HbA1c (a decrease from 8 percent to 7.7 percent) and daily blood glucose levels (a decrease from 166 mg/dL to 154 mg/dL). Treatment changes were made based upon real-time glucose information gathered in this feasibility study, together with retrospective trend data. The mean absolute difference using 1,096 sensor-meter paired readings was reported to be 17 percent. In addition, researchers found the following:

-- 42 percent of study participants discovered they needed more

basal insulin

-- 30 percent discovered they needed to deliver more insulin to

cover carbohydrate intake

-- 15 percent discovered they needed to lower their basal insulin

rate

-- 9 percent discovered they needed a correction dose to

normalize high blood sugar

"Although the patient cohort was small and the blood sugar improvement was not statistically significant, we are encouraged by the outcome which showed positive trends in blood sugar control in only four weeks," said Francine R. Kaufman, M.D., head of the Center of Diabetes and Endocrinology at Childrens Hospital of Los Angeles, professor of pediatrics at the Keck School of Medicine of University of Southern California, and immediate past president of the American Diabetes Association. "Real-time readings and glucose trends allowed us to see where glucose levels were over the past 24 hours, where they were currently, and allowed us to project where they were going to be in the near future. This patient-empowering technology helped us improve diabetes management and certainly bodes well for the use of future sensor-augmented systems."

Studies have demonstrated that treating diabetes patients to a "target" HbA1c level of 6.5 percent to 7.0 percent and below can reduce their risk of diabetes-related complications as much as 76 percent, improve health and extend life. An HbA1c test measures the average percentage of glucose concentration in the blood over a two-to-three month period. People without diabetes naturally maintain an HbA1c below 6.0 percent. Unfortunately, roughly one-third of Americans with diabetes have an HbA1c above 9.5 percent. Elevated HbA1c levels can lead to serious short- and long-term complications of diabetes, including blindness, kidney failure, amputation, impotence and heart disease.

"We are extremely encouraged by the results observed in this small patient population and look forward to initiating a large, multi-center study later this year," said Jeffery A. McCaulley, vice president and general manager of Medtronic's Diabetes business. "The ability for patients to accurately receive real-time glucose readings and make immediate diabetes management adjustments will be a major step toward the creation of an artificial pancreas. It also supports our commitment to improving lives by providing diabetes patients with tools necessary to maintain an HbA1c target of 6.5 percent to 7.0 percent and below."

Future sensor-augmented insulin pump system

When commercially available, this innovative therapy is expected to be marketed as the Paradigm(R) 522/722 sensor-augmented insulin pump system. This fully-external system will be designed to utilize a subcutaneous glucose sensor, which is easily inserted under the skin by a patient or healthcare professional, to continuously record blood sugar readings for up to three days. The system's small transmitter is designed to send continuous glucose readings via radio frequency to the pump, which is expected to display real-time glucose readings every five minutes, trend graphs and provide hypoglycemia and hyperglycemia alerts to patients, allowing them to monitor trends in their blood sugar levels and make immediate corrective adjustments using their insulin pump.

Paradigm Pathway Program

To help patients stay up-to-date with the rapid pace of medical innovations, Medtronic Diabetes has created a benchmark program allowing Paradigm customers to access new innovations in insulin pump therapy as they become available. The Paradigm Pathway Program allows Paradigm customers to purchase upgrades during their warranty period to stay current with the latest technology advancements, including today's "smart pumps" and future pumps designed to integrate continuous glucose monitoring.

Medtronic Diabetes (www.minimed.com) is the world leader in insulin pump therapy and continuous glucose monitoring systems. The company's products include external insulin pumps, related disposable products, and continuous glucose monitoring systems for professional and patient use. Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease.

EDITOR'S NOTE: Detailed information about diabetes and insulin pump therapy is available by accessing Medtronic's online newsroom at www.medtronic.com/newsroom. 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 25, 2003. Actual results may differ materially from anticipated results.
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Date:Jun 5, 2004
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