Status:
COMPLETED
Trial Between a Computer-Guided Insulin Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU
Lead Sponsor:
Emory University
Collaborating Sponsors:
Sanofi
Grady Health System
Conditions:
Diabetes or With New Hyperglycemia
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
The study is a multicenter, prospective, open-label randomized study to compare the safety and efficacy of continuous insulin infusion (CII) via a computer-guided(Glucommander) and a standard paper fo...
Detailed Description
Increasing evidence from observational studies in hospitalized patients with and without diabetes indicates that hyperglycemia is a predictor of poor outcome. Blood glucose control with intensive insu...
Eligibility Criteria
Inclusion
- Males or females between the ages of 18 and 70 years admitted to a medical ICU
- A known history of diabetes mellitus or with new hyperglycemia untreated or treated by diet, insulin therapy or with any combination of antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
- Blood glucose greater than 120 mg/dl on ≥ 2 occasions for known, treated diabetics or greater than 140 mg/dl on ≥ 2 occasions for those with new hyperglycemia.
- Subjects must have an admission blood glucose \< 400 mg/dL, without laboratory evidence of diabetic ketoacidosis (serum bicarbonate \< 18 milliequivalents/L or positive serum or urinary ketones).
Exclusion
- Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state \[38\].
- Patients with known HIV, severely impaired renal function (serum creatinine ≥3.0 mg/dl).
- Patients with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Female subjects who are pregnant or breast feeding at time of enrollment into the study.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00394524
Start Date
June 1 2006
End Date
September 1 2008
Last Update
October 30 2018
Active Locations (4)
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1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
2
Piedmont Hopsital
Atlanta, Georgia, United States, 30309
3
University of Tennessee Health Science Center, Memphis
Memphis, Tennessee, United States, 38103
4
University of Washington, Seattle
Seattle, Washington, United States, 98195