N/A
N=160
Trial Between a Computer-Guided Insulin Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU
Diabetes or With New Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT00394524 ↗Enrolled (actual)
160
Serious AEs
4.6%
Results posted
Sep 2013
Primary outcome: Primary: Mean Blood Glucose (BG) in mg/dl Among Glucommander Group Compared to Standard Insulin Infusion — 103.3; 117.3 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Glucommander (Device); Standard insulin infusion algorithm (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Emory University
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Blood Glucose (BG) in mg/dl Among Glucommander Group Compared to Standard Insulin Infusion |
103.3; 117.3 | — |
| SECONDARY Number of Patients With Severe Hypoglycemia Episodes Among the Glucommander Group Compared to Standard Algorithm |
3; 4 | — |
| SECONDARY Mean Length of Intensive Care Unit (ICU) in Days Stay Among Glucommander Group Compared to Standard Insulin Infusion Group |
8.5; 13.4 | — |
| SECONDARY Mean Hospital Length of Stay in Days Among the Glucommander Group Compared to Standard Insulin Infusion |
23.9; 17.5 | — |
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 form protocol among the patients hospitalized in a medical intensive care unit (ICU).
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Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00394524). 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.