Forbedring av subkutan insulinabsorbsjon of glukosemonitorering ved bruk av mikrodosert glukagon.
1 Purpose
The experiment aims to investigate whether using very small (almost homeopathic) doses of glucagon given subcutaneously at the same site as an insulin infusion can increase insulin absorption. The background for this idea is that glucagon has a vasodilating effect on blood vessels in the skin and thus increases the local subcutaneous blood circulation. The changes in protocol plan to investigate the effect of repeated microdoses with insulin infusions to study the cumulative effect of repeated dosing and find an optimal (minimal effective )dose for future clinical trials. The other part of the experiment aims to investigate the pharmacological interactions between insulin and glucagon (pertaining to the mixing of the drugs)
2 Adverse effects
The pigs will be sedated. After sedation, the pigs will be put under anesthesia for the experiment. These are terminal procedures, and the pigs will be euthanized at the end of the experiment day.
3 Expected utility value
Slow insulin absorption is one of the main obstacles to the fact that fully automated insulin pumps (artificial pancreas) have not yet been developed for patients with type 1 diabetes. If we can reduce this delay, the goal of a fully automated artificial pancreas is achievable, giving people with diabetes optimal glucose control, freedom from their disease, and improved quality of life.
4 Number of animals and species
We are applying for 30 pigs (Sus scrofa domesticus).
5 How to comply with the 3Rs
We have chosen to carry out main terminal procedures as per previous protocols, which have already provided justifications for the risk to the animals and the burden on the included animals. We have carried out power calculations to estimate the required number of animals. However, this calculation is primarily based on estimates because no similar experiments have been carried out previously. We have had issues publishing studies with fewer pigs in the past, affecting the generalizability of the results.
The experiment aims to investigate whether using very small (almost homeopathic) doses of glucagon given subcutaneously at the same site as an insulin infusion can increase insulin absorption. The background for this idea is that glucagon has a vasodilating effect on blood vessels in the skin and thus increases the local subcutaneous blood circulation. The changes in protocol plan to investigate the effect of repeated microdoses with insulin infusions to study the cumulative effect of repeated dosing and find an optimal (minimal effective )dose for future clinical trials. The other part of the experiment aims to investigate the pharmacological interactions between insulin and glucagon (pertaining to the mixing of the drugs)
2 Adverse effects
The pigs will be sedated. After sedation, the pigs will be put under anesthesia for the experiment. These are terminal procedures, and the pigs will be euthanized at the end of the experiment day.
3 Expected utility value
Slow insulin absorption is one of the main obstacles to the fact that fully automated insulin pumps (artificial pancreas) have not yet been developed for patients with type 1 diabetes. If we can reduce this delay, the goal of a fully automated artificial pancreas is achievable, giving people with diabetes optimal glucose control, freedom from their disease, and improved quality of life.
4 Number of animals and species
We are applying for 30 pigs (Sus scrofa domesticus).
5 How to comply with the 3Rs
We have chosen to carry out main terminal procedures as per previous protocols, which have already provided justifications for the risk to the animals and the burden on the included animals. We have carried out power calculations to estimate the required number of animals. However, this calculation is primarily based on estimates because no similar experiments have been carried out previously. We have had issues publishing studies with fewer pigs in the past, affecting the generalizability of the results.