07 Jun Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial
Thabit H. et al., Lancet Diabetes Endocrinology, 2017
An open- label, parallel- group, randomized controlled trial was conducted by Thabit H et al. to assess the safety and efficacy of fully closed-loop insulin delivery (so-called artificial pancreas), as compared to the standard subcutaneous insulin therapy in patients with type 2 diabetes mellitus. During the one year study period, 40 patients aged 18 years and above, from general ward were randomized to receive closed- loop insulin delivery (using a model-predictive control algorithm to direct subcutaneous delivery of rapid-acting insulin analogue without meal-time insulin boluses) or the conventional subcutaneous insulin delivery. The primary outcome i.e.; time spent in the target glucose concentration range of 5.6-10.0 mmol/L during the 72 hour study period; was 59·8% (SD 18·7) in the closed-loop group and 38·1% (16·7) in the control group (difference 21·8% [95% CI 10·4–33·1]; p=0·0004). No episodes of severe hypoglycaemia or hyperglycaemia with ketonaemia were observed in either group. Thus, closed- loop insulin delivery without meal-time boluses is safe and efficacious in insulin-treated adults with type 2 diabetes in the general ward.