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; HbA1c: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 AUC0–60) after insulin bolus was increased by 29.7 ± 7% on day 1 InsuPatch versus day 1 control (p