Improved pharmacokinetic and pharmacodynamic profiles of insulin analogues using InsuPatch, a local heating device

Background: Previous studies have shown that heating the insulin injection site may accelerate insulin absorption. We investigated the pharmacological profile of insulin administered with InsuPatch, a local skin-heating device. Methods: In this randomized, crossover study carried out in 56 subjects with type 1 diabetes treated with insulin pump [mean age 32±13.5 years; 23 women; HbA_1c:7.8±0.9% (62±10 mmol/mol) (mean+/-standard deviation)]. Euglycemic glucose clamps were performed after administration of 0.15 units/kg of short-acting insulin analogues. Each subject underwent three clamp procedures: two with the InsuPatch device (day 1 and day 3) and one without the device (day 1 control). The primary endpoints were the following: (1) the change in the area under the curve (AUC) of insulin during the first 60 min post-insulin bolus on day 1 with the InsuPatch device versus day 1 control and (2) parameters to assess the safety of using the device. Results: The area under the curve of insulin during the initial 60 min (insulin AUC_0-60) after insulin bolus was increased by 29.7±7% on day 1 InsuPatch versus day 1 control (p<0.01). Maximal post-insulin bolus concentration was 57 mU/L on day 1 InsuPatch versus 47.6 mU/L on day 1 control (p<0.01). On day 3 InsuPatch, insulin AUC_0-60 was increased by 27.9±72% versus day 1 InsuPatch (p<0.01). Maximal insulin concentration was 70.4 mU/L versus 57 mU/L, respectively (p=0.05). Conclusions: The use of the heating device upon administration of short-acting insulin analogues in pump-treated type 1 diabetic patients was found to enhance insulin absorption. This heating device may therefore serve to achieve better meal insulin coverage.