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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00166491
• Date of registration: 12/09/2005
• Primary sponsor: Mayo Clinic
• Public title: Comparing Two Ways of Controlling Blood Sugar With Insulin in Patients Admitted to the Intensive Care Unit
• Scientific title: Comparison of Two Approved Insulin Infusion Protocols for Glycemic Control in Critically Ill Patients
• Date of first enrolment: July 2005
• Target sample size: 238
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00166491
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Roy K. Tuhin, M.D., Ph.D.
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

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



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Critical Illness

Hyperglycemia

Intervention(s)

Drug: Insulin

Primary Outcome(s)

Mean blood glucose level during study period [mg/dl]

Percentage of time points within range during protocol (serum glucose 60-150 mg/dl) [%]

Secondary Outcome(s)

Maximum blood glucose level during study period [mg/dl]

Mean hourly intravenous (IV) insulin dose calculated daily [units/hour]

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]

Time from initiation of protocol to first measurement in target range (serum glucose 60-150 mg/dl) [hours]

Secondary ID(s)

22-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors