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Intensive blood sugar treatment in trial of diabetes and cardiovascular disease changed
Date:2/6/2008

idemiology, patient care, biostatistics, medical ethics, and clinical trial design that has been monitoring ACCORD since it began. A specific charge of any DSMB is to monitor participant safety.

ACCORD participants will continue to receive blood sugar treatment from their study clinicians until the planned trial conclusion in June 2009. Those participants in the intensive treatment group will now be treated to the same A1C goals as those already in the standard treatment group.

The intensive treatment group had a target blood sugar goal, measured by hemoglobin A1C, of less than 6 percent. This is similar to blood sugar levels in adults without diabetes. The standard treatment group aimed for a target similar to what is achieved, on average, by those with diabetes in the United States (A1C of 7 to 7.9 percent) and lower than at study entry.

The ACCORD findings are important, but will not change therapy for most patients with type 2 diabetes. Few patients with high cardiovascular risk like those studied in ACCORD are treated to blood sugar levels as low as those tested in this study, said Judith Fradkin, M.D., director, Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). People with diabetes should never adjust their treatment plan or goals without consulting their health care providers.

In ACCORD, intensive treatment group participants achieved, on average, A1C values lower than standard treatment group participants. Half of the participants in the intensive treatment group achieved an A1C of less than 6.4 percent, and half of the participants in the standard treatment group achieved an A1C of less than 7.5 percent. The average blood sugar levels for both groups were lower than when they entered the study.

The ACCORD trial was designed to determine whether intensively lowering blood sugar would reduce the risk of cardiovascular e
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