Study Description: Stroke is the third leading cause of death and leading cause of adult disability in the United States. Stroke occurs in nearly 800,000 people in the U.S. each year with approximately 85% of them being ischemic and 40% of ischemic strokes being hyperglycemic at presentation to the hospital. Hyperglycemia, or high blood sugar, is associated with poorer clinical outcomes. This trial will determine the efficacy and provide further safety data on sugar control in stroke patients who present with type 2 diabetes and a blood sugar level >110 or, in patients without a history of diabetes a blood sugar level >150. The hyperglycemic acute stroke patients that meet all eligibility criteria will receive up to 72 hours of IV insulin therapy or control therapy with subcutaneous (SQ) insulin. Treatment will start within 12 hours of symptom onset. A validated computer program will guide delivery of the IV insulin therapy. The NIH Stroke Scale (NIHSS) and modified Rankin Scale (mRS) will be used to measure the stroke severity and assess improvement after stroke. Health care providers are currently making clinical decisions regarding hyperglycemia without adequate data. The information gained from this efficacy trial will guide clinical practice and provide answers regarding the risks and benefits of glucose control to improve stroke outcomes.
Principal Investigator: Askiel Bruno
Eligibility Criteria: Age 18 years or older Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH). Protocol treatment must begin within 3 hours after hospital arrival and within 12 hours after stroke symptom onset. Known history of type 2 diabetes mellitus and glucose >110mg/dL OR admission glucose >150mg/dL in those without known diabetes mellitus Baseline NIHSS score of 3-22 Pre-stroke mRS score of 0 Able to provide a valid informed consent to be in the study.
Compensation: Yes, subjects will be compensated.
Compensation Explanation: This is in the form of a one time payment for the 90 day follow-up clinic visit: You will not receive payment for participating in this study. However, you may receive reimbursement in the amount of $25 to compensate for transportation costs to AU in order to complete the 3 month visit. This will be in the form of a ClinCard that you should receive at your request during your visit.
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