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Trial Between a Computer-Guided Insulin Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU

CompletedNA

Sponsor: Emory University

Conditions: Diabetes or With New Hyperglycemia

Interventions: Glucommander, Standard insulin infusion algorithm

Countries: United States

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 form protocol among the patients hospitalized in a medical intensive care unit (ICU). .

Eligibility overview

Sex: FEMALE

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Males or females between the ages of 18 and 70 years admitted to a medical ICU
2. 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.
3. 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 Criteria:

1. Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state \[38\].
2. Patients with known HIV, severely impaired renal function (serum creatinine ≥3.0 mg/dl).
3. Patients with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
4. Female subjects who are pregnant or breast feeding at time of enrollment into the study.

Locations (4)

Atlanta, Georgia, United States
Atlanta, Georgia, United States
Memphis, Tennessee, United States
Seattle, Washington, United States