Comparing Two Ways of Controlling Blood Sugar With Insulin in Patients Admitted to the Intensive Care Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00166491
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 18, 2011
Information provided by:
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Critical Illness Hyperglycemia Drug: Insulin Not Applicable

Detailed Description:
Improved outcomes have been demonstrated with tight control of blood glucose in critically ill patients. A number of look-up algorithms based on hourly glucose measurements and titrated intravenous insulin have been developed for the intensive care unit (ICU). Despite the numerous published algorithms, no study has investigated which algorithm results in optimal glycemic control in critically ill patients. The purpose of this trial is to compare two institutionally approved intravenous insulin administration algorithms and describe subsequent glycemic control. We hypothesize that the protocol that allows for variable insulin administration for a given blood glucose (multiple algorithms) will be associated with more optimal glycemic control. Optimal glycemic control will be defined by time spent within a predetermined blood glucose range. In addition, the number of hypoglycemic episodes and mean and maximum blood glucose concentrations will also be measured. This trial will determine which insulin infusion algorithm is most effective in terms of glycemic control, and allow for standardization of glucose management in accordance with best practice.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Comparison of Two Approved Insulin Infusion Protocols for Glycemic Control in Critically Ill Patients
Study Start Date : July 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Primary Outcome Measures :
  1. Percentage of time points within range during protocol (serum glucose 60-150 mg/dl) [%]
  2. Mean blood glucose level during study period [mg/dl]

Secondary Outcome Measures :
  1. Time from initiation of protocol to first measurement in target range (serum glucose 60-150 mg/dl) [hours]
  2. Number of time points below range (hypoglycemic episodes with serum glucose < 60) normalized by study period [hypoglycemic glucose determinations/total glucose determinations]
  3. Time enrolled in the trial [hours]
  4. Maximum blood glucose level during study period [mg/dl]
  5. Mean hourly intravenous (IV) insulin dose calculated daily [units/hour]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients admitted to the 7MB D/E ICU will be eligible for this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00166491

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Roy K. Tuhin, M.D., Ph.D. Mayo Clinic Identifier: NCT00166491     History of Changes
Other Study ID Numbers: 22-05
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: April 18, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Critical Illness
Glucose Metabolism Disorders
Metabolic Diseases
Disease Attributes
Pathologic Processes
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs