Comparing Two Ways of Controlling Blood Sugar With Insulin in Patients Admitted to the Intensive Care Unit
Comparison of Two Approved Insulin Infusion Protocols for Glycemic Control in Critically Ill Patients
1 other identifier
interventional
238
1 country
1
Brief Summary
The purpose of this study is to determine if there is any difference between two ways of controlling blood sugar with insulin. In patients admitted to the intensive care unit, blood sugar levels often rise due to the stress of illness or surgery. Studies have shown that patients do better if their blood sugar is kept normal. In order to maintain normal blood sugar levels, the investigators often give insulin (a substance made by the body), and they decide how much to give based on how high the blood sugar is. This study will compare two different ways of deciding how much insulin to give and compare how well each method keeps the blood sugar in a normal range. Both ways of controlling blood sugar are institutionally-approved protocols and part of routine care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedApril 18, 2011
April 1, 2011
1.7 years
September 12, 2005
April 15, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of time points within range during protocol (serum glucose 60-150 mg/dl) [%]
Mean blood glucose level during study period [mg/dl]
Secondary Outcomes (5)
Time from initiation of protocol to first measurement in target range (serum glucose 60-150 mg/dl) [hours]
Number of time points below range (hypoglycemic episodes with serum glucose < 60) normalized by study period [hypoglycemic glucose determinations/total glucose determinations]
Time enrolled in the trial [hours]
Maximum blood glucose level during study period [mg/dl]
Mean hourly intravenous (IV) insulin dose calculated daily [units/hour]
Interventions
Eligibility Criteria
You may qualify if:
- All patients admitted to the 7MB D/E ICU will be eligible for this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roy K. Tuhin, M.D., Ph.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 14, 2005
Study Start
July 1, 2005
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
April 18, 2011
Record last verified: 2011-04