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

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 157
• Participant gender: Female

Summary

High blood sugars increase the risk of complications and death in diabetic patients admitted to the hospital. Recent studies hve shown that strict blood sugar control with intravenous (IV) insulin lowers the risk of such complications and death in the ICU. Several insulin infusion protocols have been reported in the literature, but it is not known which is the best. These protocols use tables and formulas that may be confusing and difficult to follow. To facilitate patient care, insulin protocols could be placed on a computer and used at the patient's bedside to direct the nursing staff administering the IV insulin. The Glucommander is one of such computer-derived insulin infusion protocol which has been used successfully in patients with diabetes since 1984. We hypothesize that management of inpatient hyperglycemia with a computer-guided intravenous infusion protocol will facilitate smoother glycemic control with a lower rate of low blood sugars than treatment following a standard insulin infusion algorithm in the medical intensive care unit. We will aim to determine differences in glycemic control between treatment with a computer-guided intravenous infusion protocol (Glucommander) and a standard insulin infusion algorithm in critically ill patients in the ICU.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborators: Grady Memorial Hospital, Atlanta; Piedmont Hospital, Atlanta; Sanofi; University of Tennessee
• Treatments: Insulin; Insulin glulisine; Insulin, Globin Zinc
• Last Updated: 2013-11-12

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.