Joint Statement From the American Diabetes Association and American Association of Clinical Endocrinologists on the

ALEXANDRIA, VA and JACKSONVILLE, FL, Mar 24 (MARKET
WIRE) --
A study published online today in the New England Journal of Medicine
suggests that intensive blood glucose (sugar) control for critical care
patients with hyperglycemia (high blood glucose) does not improve
outcomes and is associated with an increase in deaths.

The American Diabetes Association (ADA) and the American Association of
Clinical Endocrinologists (AACE) maintain that the findings of the
Normoglycemia in Intensive Care Evaluation-Survival Using Glucose
Algorithm Regulation (NICE-SUGAR) study should NOT lead to an abandonment
of the concept of good glucose management in the hospital setting.
Uncontrolled high blood glucose can lead to serious problems for
hospitalized patients, such as dehydration and increased propensity to
infection.

It is important to consider that the severely ill patients in this trial
were treated intensively with intravenous insulin to very tight targets
(average of 115 mg/dl), and were compared to a control group whose glucose
control was good (average glucose 144 mg/dl).

The ADA and AACE caution against letting this study swing the pendulum of
glucose control too far in the other direction where providers in
hospitals are complacent about uncontrolled hyperglycemia. The two
organizations maintain that strategies must be identified to help
hospitals establish structured protocols for safe and effective
management of blood glucose in both intensive care units and other
hospital settings.

"Since 2003, AACE and the ADA have worked together to provide
recommendations for treatment of inpatient hyperglycemia, and these
efforts have contributed to a growing national movement viewing the
management of hyperglycemia in hospitals as a quality care measure," Dr.
Etie S. Moghissi, AACE Chair of Inpatient Glycemic Control Task Force
said.

Recognizing the critical importance of controlling hyperglycemic states in
conjunction with the results of recent randomized trials such as
NICE-SUGAR, the two organizations recently convened a Consensus Panel to
extensively review the most current literature and up-to-date
recommendations for treatment of hyperglycemia in the hospital.

"The central goal of the ADA/AACE inpatient task force is to identify
reasonable, achievable, and safe glucose targets, and to describe the
protocols, procedures, and system improvements needed to achieve inpatient
optimal glucose control efficiently and safely," Dr. Mary Korytkowski, ADA
Chair of Inpatient Glycemic Control Task Force said.

Complete recommendations from the panel will be published in Endocrine
Practice and Diabetes Care later in the spring. Until more information is
available, it seems reasonable for clinicians to treat critical care
patients with the less intensive -- yet good -- glucose control strategies
used in the conventional arm of the NICE-SUGAR trial.

About The NICE-SUGAR Study

Hyperglycemia in the hospital, whether it occurs in patients with known
diabetes or is temporarily stress-induced, has long been known to be
associated with poor outcomes such as longer length of stay, increased
rates of infection, and in-hospital death. Observational studies and early
randomized trials have suggested that lowering glucose levels can improve
outcomes, especially in critical care patients treated with intravenous
insulin to a range of 80-110 mg/dl. More recent studies in the critical
care population were unable to replicate earlier studies, and identified
severe hypoglycemia (low blood glucose) as a significant risk of intensive
glucose control. The NICE-SUGAR trial was a very large multicenter,
multinational study (with 6,104 participants) designed to definitively
examine the risks and benefits of intensive glucose control in critical
care units.

Results from the NICE-SUGAR study indicate that critically ill patients
treated in the intensive glucose control group were 14 percent more likely
to die compared to critically ill patients in the conventional glucose
control group.

More than 6,100 patients with hyperglycemia in critical care units were
randomized to either intensive glucose control (insulin infusion with
target blood glucose between 80-108 mg/dl) or to conventional glucose
control (insulin infusion begun if blood glucose was over 180 mg/dl, and
discontinued if blood glucose dropped below 144 mg/dl). Severe
hypoglycemia (blood glucose below 40 mg/dl) occurred in approximately 6.8
percent of intensively treated patients compared to 0.5 percent of
conventionally treated patients. The study showed no difference in length
of time in the intensive care unit or in the hospital, or in other major
outcomes such as time on ventilators or need for dialysis.

About the American Diabetes Association (ADA)

The American Diabetes Association is leading the fight against the deadly
consequences of diabetes and fighting for those affected by diabetes. The
Association funds research to prevent, cure and manage diabetes; delivers
services to hundreds of communities; provides objective and credible
information; and gives voice to those denied their rights because of
diabetes. Founded in 1940, our mission is to prevent and cure diabetes and
to improve the lives of all people affected by diabetes. For more
information please call the American Diabetes Association at
1-800-DIABETES (1-800-342-2383) or visit www.diabetes.org. Information
from both these sources is available in English and Spanish.

About the American Association of Clinical Endocrinologists (AACE)

AACE is a professional medical organization with more than 6,200 members
in the United States and 92 other countries. Founded in 1991, AACE is
dedicated to the optimal care of patients with endocrine problems. AACE
initiatives inform the public about endocrine disorders. AACE also
conducts continuing education programs for clinical endocrinologists,
physicians whose advanced, specialized training enables them to be
experts in the care of endocrine disease, such as diabetes, thyroid
disorders, growth hormone deficiency, osteoporosis, cholesterol
disorders, hypertension and obesity. For more information, please call
the AACE office at 904-353-7878 or visit www.aace.com.

Note to editors: To obtain a copy of the study, visit www.nejm.org

Contact:
Diane Tuncer, ADA
703.299.5510
dtuncer@diabetes.org

Greg Willis, AACE
904.353.7878 ext. 147
gwillis@aace.com

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