The Effect of a Liberal Approach to Glucose Control in Critically Ill Patients with Type 2 Diabetes: A multicenter, parallel-group, open-label, randomized clinical trial.

Abstract

Rationale Blood glucose concentrations affect outcomes in critically ill patients but the optimal target blood glucose range in those with type 2 diabetes is unknown. Objective To evaluate the effects of a 'liberal' approach to targeted blood glucose range during intensive care unit (ICU) admission. Methods This mutlicenter, parallel-group, open-label, randomized clinical trial included 419 adult patients with type 2 diabetes expected to be in the ICU on at least three consecutive days. In the intervention group intravenous insulin was commenced at a blood glucose >252 mg/dL and titrated to a target range of 180 to 252 mg/dL. In the comparator group insulin was commenced at a blood glucose >180 mg/dL and titrated to a target range of 108 to 180 mg/dL. The primary outcome was incident hypoglycemia (<72 mg/dL). Secondary outcomes included glucose metrics and clinical outcomes. Main Results At least one episode of hypoglycemia occurred in 10 of 210 (5%) patients assigned the intervention and 38 of 209 (18%) patients assigned the comparator (incident rate ratio: 0.21 (95% CI, 0.09 to 0.49); P<0.001). Those assigned the intervention had greater blood glucose concentrations (daily mean, minimum, maximum), less glucose variability and less relative hypoglycaemia (P<0.001 for all comparisons). By day 90, 62 of 210 (29.5%) in the intervention and 52 of 209 (24.9%) in the comparator group had died (absolute difference 4.6 percentage points (95%CI, -3.9 to 13.2%); P=0.29). Conclusions A liberal approach to blood glucose targets reduced incident hypoglycemia but did not improve patient-centered outcomes. Clinical trial registration available at www.anzctr.org.au, ID: ACTRN12616001135404.