The study is funded by a $25 million grant from the National Institutes of health and is being led by the University of Virginia Health System.
The trial is being coordinated through Neurological Emergencies Treatment Trials (NETT) network, which is based at U-M. The NETT network consists of 17 regional hubs, each with several community hospital spokes, a statistical and data management center and a clinical coordinating center.
More than 750,000 people in the United States suffer from strokes annually, and an estimated 40 percent of patients with acute ischemic stroke have high blood sugar, or hyperglycemia. Although hyperglycemia is known to be associated with worse patient outcomes (death and disability), it is unclear if treatment interventions intended to bring blood sugar to normal levels can improve these outcomes without incurring the added risk of inducing hypoglycemia (low blood sugar levels).
With this new clinical trial, called Stroke Hyperglycemia Insulin Network Effort (SHINE), researchers hope to determine the efficacy of a novel approach to controlling sugar in the early period after stroke in diabetic stroke patients.
Research sites across the country – including U-M – will be testing the current standard treatment against the new treatment, which involves the administration of a controlled IV insulin infusion therapy within 12 hours of the onset of stroke symptoms and lasting for up to three days. Eligible subjects will have diabetes and elevated blood glucose (at least greater than 110 mg/dL) on initial evaluation and will have to get to the hospital very quickly after the start of symptoms.
William Barsan, M.D., chair of the U-M’s Department of Emergency Medicine and principal investigator for the NETT Clinical Coordinating Center.
“We are very proud and excited to be part of this research effort that has the potential to improve outcomes for a large number of stroke patients,” says William Barsan, M.D., chair of the U-M’s Department of Emergency Medicine and principal investigator for the NETT Clinical Coordinating Center.
The SHINE trial is being sponsored by the NIH – National Institutes of Neurological Diseases and Stroke (NINDS).
Calling 911 as soon as someone suspects a stroke is still the most important thing for the public to remember so that doctors can rapidly treat and try to reverse stroke symptoms.