Provision of a Diabetic Preclinical Study For University of Galway

Descriptions

The CRO (contract research organisation) will perform an animal study to test the efficacy and safety of a soft robotic infusion set cannula developed in University of Galway (UG). The site must have expertise in the induction of a type 1 diabetes in Swine, the diffusion of insulin and the measurement of blood glucose. The site must have capacity to source and care for swine post-operatively for up to 5 weeks in line with EU animal welfare guidelines.The site must be able to give a competitive offering of in-study analysis and post operative organ collection, to best evaluate the efficacy of 2 diffusion methods of insulin during the study completion. It is expected the CRO will have ethics approval to cover the study.UG is proposing the following study but is open to suggestions of changes to the study design to get better value for money (including number of animals in groups). The proposed study will involve:3 arms of a study. 3 diabetic swine in arms 2 and 3, 1 health swine in arm 1.oArm 1. Experimental acute arm (Healthy swine with needle insertion of our cannula & gold standard cannula into subcutaneous tissue). 30 day follow up. (n=1)oArm 2. A passive treatment arm (implantation of cannula and passive diffusion of insulin with blood glucose measurements at specified timepoints). 30 day follow up. (n=3)oArm 3. An active treatment arm (implantation of cannula and active diffusion of insulin with blood glucose measurements at specified timepoints). 30 day follow up.