Joint Statement from the American Diabetes Association and American Association of...

Joint Statement from the American Diabetes Association and American
Association of Clinical Endocrinologists on the NICE-SUGAR Study on Intensive
Versus Conventional Glucose Control in Critically Ill Patients

Response to March 24 article in the New England Journal of Medicine

ALEXANDRIA, Va. and JACKSONVILLE, Fla., March 24 /PRNewswire-USNewswire/ -- 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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090324/DC88061LOGO-a)
(Logo: http://www.newscom.com/cgi-bin/prnh/20090324/DC88061LOGO-b)

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 http://www.nejm.org/

SOURCE American Association of Clinical Endocrinologists; American Diabetes
Association

Diane Tuncer, ADA, +1-703-299-5510, dtuncer@diabetes.org; or Greg Willis,
AACE, +1-904-353-7878 ext. 147, gwillis@aace.com