title: A prospective randomised multi-centre controlled trial on tight glucose control by intensive insulin therapy in adult intensive care units: the Glucontrol study.
abstract: OBJECTIVE
  An optimal target for glucose control in ICU patients remains unclear. This prospective randomized controlled trial compared the effects on ICU mortality of intensive insulin therapy (IIT) with an intermediate glucose control.
  
  
  METHODS
  Adult patients admitted to the 21 participating medico-surgical ICUs were randomized to group 1 (target BG 7.8-10.0 mmol/L) or to group 2 (target BG 4.4-6.1 mmol/L).
  
  
  RESULTS
  While the required sample size was 1,750 per group, the trial was stopped early due to a high rate of unintended protocol violations. From 1,101 admissions, the outcomes of 542 patients assigned to group 1 and 536 of group 2 were analysed. The groups were well balanced. BG levels averaged in group 1 8.0 mmol/L (IQR 7.1-9.0) (median of all values) and 7.7 mmol/L (IQR 6.7-8.8) (median of morning BG) versus 6.5 mmol/L (IQR 6.0-7.2) and 6.1 mmol/L (IQR 5.5-6.8) for group 2 (p < 0.0001 for both comparisons). The percentage of patients treated with insulin averaged 66.2 and 96.3%, respectively. Proportion of time spent in target BG was similar, averaging 39.5% and 45.1% (median (IQR) 34.3 (18.5-50.0) and 39.3 (26.2-53.6)%) in the groups 1 and 2, respectively. The rate of hypoglycaemia was higher in the group 2 (8.7%) than in group 1 (2.7%, p < 0.0001). ICU mortality was similar in the two groups (15.3 vs. 17.2%).
  
  
  CONCLUSIONS
  In this prematurely stopped and therefore underpowered study, there was a lack of clinical benefit of intensive insulin therapy (target 4.4-6.1 mmol/L), associated with an increased incidence of hypoglycaemia, as compared to a 7.8-10.0 mmol/L target. (ClinicalTrials.gov # NCT00107601, EUDRA-CT Number: 200400391440).
authors.affiliation: Department of General Intensive Care, University Hospital, Liege, Belgium. Jean-Charles.Preiser@chu.ulg.ac.be
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Preiser
authors.forename: Philippe
authors.initials: P
authors.lastname: Devos
authors.forename: Sergio
authors.initials: S
authors.lastname: Ruiz-Santana
authors.forename: Christian
authors.initials: C
authors.lastname: Mélot
authors.forename: Djillali
authors.initials: D
authors.lastname: Annane
authors.forename: Johan
authors.initials: J
authors.lastname: Groeneveld
authors.forename: Gaetano
authors.initials: G
authors.lastname: Iapichino
authors.forename: Xavier
authors.initials: X
authors.lastname: Leverve
authors.forename: Gérard
authors.initials: G
authors.lastname: Nitenberg
authors.forename: Pierre
authors.initials: P
authors.lastname: Singer
authors.forename: Jan
authors.initials: J
authors.lastname: Wernerman
authors.forename: Michael
authors.initials: M
authors.lastname: Joannidis
authors.forename: Adela
authors.initials: A
authors.lastname: Stecher
authors.forename: René
authors.initials: R
authors.lastname: Chioléro
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000032:analysis*; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000097:blood* / Q000188:drug therapy*; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin