N/A
N=151
Comparative Trial Between 3 Types of Insulin Infusion Protocols
Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT00582309 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcome: Primary: Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group. — 5; 10.1; 7.7 Time to reach glycemic control in hours — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Glucommander-Guided Intravenous Insulin Infusion (Procedure); Standard Intravenous Insulin Infusion (Procedure); Simple Calculated Intravenous Insulin Infusion (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group. |
5; 10.1; 7.7 | <0.05 sig |
Summary
Increasing evidence from observational studies in hospitalized patients with and without diabetes indicates that hyperglycemia is a predictor of poor outcome. Over the short-term, hyperglycemia can adversely affects fluid balance (through glycosuria and dehydration), impairs immunologic response to infection, and promotes inflammation and endothelial dysfunction. Blood glucose control with intensive insulin therapy in patients with acute critical illness reduces the risk of multiorgan failure and systemic infections, and decreases short- and long-term mortality .
- Hypotheses: we hypothesize that management of inpatient hyperglycemia with a computer-guided intravenous infusion protocol (Glucommander) will facilitate a smoother glycemic control with a lower rate of hypoglycemic events than treatment following a standard insulin infusion algorithm or a simple calculated infusion protocol in critically ill patients in the medical and surgical ICU.
Eligibility Criteria
Inclusion Criteria
- Patients who are admitted to Medical or Surgical ICU.
- History of diabetes mellitus
- Newly diagnosed hyperglycemia (defined as a blood glucose greater than 140 mg/dl on ≥ 2 occasions)
- Subjects must have an admission blood glucose < 500 mg/dL, without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).
Exclusion Criteria
- Non-Diabetic patients
- Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
- Patients with known HIV
- Patients with 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
Data sourced from ClinicalTrials.gov (NCT00582309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.