Milpitas, Calif., December 17, 2001 - The U.S. Food and Drug Administration has cleared blood glucose testing guidelines developed by LifeScan, Inc. for alternate site testing with three of the company's products. The new guidelines explain the proper role of alternate site blood glucose testing, a less painful alternative to traditional fingertip testing for people with diabetes ¹. The guidelines also answer many of the questions about alternate site testing so that more people with diabetes can use this appealing testing option with confidence. They were developed for use with the OneTouch® Ultra and OneTouch® FastTake® Blood Glucose Monitoring Systems, and the InDuo® System, all products of LifeScan, a Johnson & Johnson company ².

In June of 2000, LifeScan made alternate site testing widely available to people with diabetes, who rely on their blood glucose test results to help them manage their disease and reduce their risk of serious complications. Alternate site testing allows the user to obtain the necessary blood sample for a glucose test from a body site other than the fingertip, which is the traditional site for a blood glucose test. In addition to fingertip testing, the three LifeScan products are cleared for alternate site testing on the forearm, which has fewer nerve endings than the fingertip and is less painful for many people.

The LifeScan guidelines provide new, clinically based information ³ about when it's most appropriate to use each of the two different blood glucose testing methods. The guidelines are significant because there can be differences between glucose results obtained from tests on the fingertips and those obtained from tests on an alternate site, such as the forearm. In fact, because body tissues use glucose at different rates, it's possible for a person to test on two different parts of the body at the same point in time and get different test results. The conditions under which these differences are most likely to occur are when blood glucose levels are changing rapidly, such as following a meal, an insulin dose or physical exercise.

Highlights of the new LifeScan testing guidelines point out that ⁴:

• When testing less than 2 hours after meals, after insulin doses, or after physical exercise, patients should test from the fingertip.
  
• At all other times, including routine testing before meals, patients can use either the fingertip or arm (whichever is preferred).
  
• Patients should also consult their healthcare professional before beginning to use the arm for testing.

"We are pleased that we could work together with the FDA to develop guidelines that will help people with diabetes understand when and how to safely use this pain-saving method for blood glucose testing," said David Horwitz, M.D., Ph.D., vice president of medical and regulatory affairs for LifeScan.

LifeScan, a leading maker of blood glucose monitoring products, is dedicated to creating a world without limits for people with diabetes. More diabetes specialists recommend the company's
OneTouchâ Blood Glucose Monitoring Systems than any other brand. Every day, more than three million people rely on OneTouchâ Systems for simple testing and accurate results. For healthcare professional resources, and for information about diabetes care and LifeScan products and services, visit www.LifeScan.com.

Important Information ABOUT ARM TESTING

• Under certain conditions, blood glucose test results obtained using samples taken from your arm may differ significantly from fingertip samples.
• The conditions in which these differences are most likely to occur are when your blood glucose is changing rapidly such as following a meal, an insulin dose or associated with physical exercise.
• When blood glucose is changing rapidly, fingertip samples show these changes more quickly than arm samples.
• When your blood glucose is falling, testing with a fingertip sample may identify a hypoglycemic (low blood sugar) level sooner than a test with an arm sample.
• Use arm samples only for testing prior to, or more than 2 hours after, meals, insulin dosing or physical exercise.
• Testing performed within two hours after a meal, an insulin dose or physical exercise, or whenever you feel that your glucose levels may be changing rapidly, should be done from the fingertip.
• You should also use fingertip testing whenever you have a concern about hypoglycemia (insulin reactions) such as when driving a car, particularly if you suffer from hypoglycemic unawareness (lack of symptoms to indicate an insulin reaction), as arm testing may fail to detect hypoglycemia.

What you should do:

• Routine testing before meals can be done either at the fingertip or the arm.
• Consult your healthcare professional before you begin using the arm for testing.

1. In a clinical study conducted in 2000 at the New England Center for Diabetes and Endocrinology, nearly four out of five people (78%) reported that blood glucose testing on the arm was painless or significantly less painful than fingertip testing.
2. The InDuo System is the world's first combined insulin doser and blood glucose monitor, and is jointly developed and marketed by LifeScan and Novo Nordisk, a manufacturer of insulin and insulin delivery systems.
   
3. Research conducted at LifeScan, Milpitas, CA, December 2000 and March 2001.
4. Please see below for a complete listing of LifeScan's new labeling guidelines for blood glucose testing on the arm.

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