August 17, 2011 - Charlottesville, VA - The University of Virginia has received a $25 million grant that could lead to breakthroughs for diabetic stroke patients. The grant, from the National Institutes of Health, provides money for UVa to lead a 56-center nationwide clinical trial of a new treatment for acute stroke victims with hyperglycemia, or high blood sugar. According to Karen Johnston, chair of the UVa Department of Neurology and principal investigator of the study, the new treatment applies to diabetic stroke victims. “The people who will be eligible for this research will be hyperglycemic acute stroke patients,” Johnston said. “All or nearly all will have diabetes.”

The new treatment involves giving patients an insulin IV starting within 12 hours of a stroke for up to three days. The amount of insulin will be determined using MAS Informatics GlucoStabilizer insulin dosing software, which calculates the IV dose based on the patient’s current glucose reading and instructs the caregiver to adjust the IV drip accordingly. GlucoStabilizer was selected for use in the study based on its performance and widely used acceptance in critical care settings throughout the country, as well as its unique computer networking capability.

According to Johnston, strokes are defined as acute for a short time after symptoms begin. After 12 hours, she said, the stroke is no longer considered acute. Johnston added that getting to a hospital as soon as possible is critical for proper treatment. “For this trial, we have to start the treatment within 12 hours of the first symptoms and within three hours of arriving to the hospital,” Johnston said. The research effort, called Stroke Hyperglycemia Insulin Network Effort (SHINE), will determine whether insulin treatments after the onset of a stroke will improve the outcome of a stroke for patients with high blood sugar. Elevated blood sugar makes stroke sufferers more likely to die or be disabled by a stroke. The research will determine whether insulin therapy can improve outcomes without giving patients low blood sugar. “The trial will compare a treatment that will rapidly and continuously keep the glucose levels in a very tight normal range versus a treatment that will more gently lower the glucose levels and allow them to stay a little higher,” Johnston said.

To compare the treatment to others, the hospital will randomize whether patients who volunteer to participate get the experimental procedure or a conventional treatment. According to Johnston, a computer will randomize which patient gets which treatment. The computer will give preference to the treatment that appears most effective. “One unique thing about this trial is that for patients who want to participate in the trial, they will be assigned to one treatment or the other, but will have a slightly better chance of getting whichever treatment is doing better, even though doctors won’t even know that information,” Johnston said.

According to UVa, of the 750,000 people who suffer a stroke each year, 40 percent are hyperglycemic. Johnston stressed that getting to a hospital immediately after symptoms begin is critical to proper stroke treatment, regardless of whether a patient is diabetic. “If you or someone you know is having a stroke, get to the hospital fast so doctors can begin treatment immediately,” she said.