NCT00240149 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Capes SE, Hunt D, Malmberg K, Gerstein HC
Stress hyperglycaemia and increased risk of death after myocardial infarction in patients with and without diabetes: a systematic overview. Lancet. 2000 Mar 4;355(9206):773-8. Review.
Cochran A, Scaife ER, Hansen KW, Downey EC
Hyperglycemia and outcomes from pediatric traumatic brain injury. J Trauma. 2003 Dec;55(6):1035-8.
Finney SJ, Zekveld C, Elia A, Evans TW
Glucose control and mortality in critically ill patients. JAMA. 2003 Oct 15;290(15):2041-7.
Srinivasan V, Spinella PC, Drott HR, Roth CL, Helfaer MA, Nadkarni V
Association of timing, duration, and intensity of hyperglycemia with intensive care unit mortality in critically ill children. Pediatr Crit Care Med. 2004 Jul;5(4):329-36.
The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus
The Diabetes Control and Complications Trial Research Group. N Engl J Med. 1993 Sep 30;329(14):977-86.
van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R
Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67.
Wintergerst KA, Buckingham B, Gandrud L, Kache S, Wilson DM
Hyperglycemia in the Pediatric Intensive Care Unit. Abstract. Diabetes Technology & Therapeutics 7(2):422, 2005.

Pilot Study Evaluating Use of Insulin-Glucose Algorithm and Glucose Monitoring Techniques to Control Hyperglycemia in the Pediatric Intensive Care Unit

Details for clinical trial NCT00240149

Clinical trial NCT00240149 - References