Endocrine Abstracts

Introduction

Diabetes, a metabolic disorder characterized by abnormal blood glucose levels, is a serious chronic disease that implies an important public health problem. Being Insulin the main hormone for modulating blood glucose levels, subcutaneous injections are the main way for its administration in the diabetes treatment. However, this way of administration can lead to poor patient compliance, apart from several side-effects. Although other ways of administration have been investigated, such as oral or inhaled insulin, these have enough drawbacks to not be consider as substitutes of subcutaneous injections. To face this problem, Medicsen is developing a Smartpatch that integrates a wide range of technologies, all of them tested in laboratory, with the purpose of ensuring the correct transport of insulin from the surface of the skin to the bloodstream using a non-invasive and painless way through a phenomenon induced by the sonophoresis.

Materials and methods

Several in vitro and in vivo tests have been performed in order to prove the efficacy and safety of the technology, allowing us to collect experimental evidence through different methodologies that demonstrate the therapeutic potential of the device. Among these methodologies there are permeability studies using Franz diffusion Cell and swine models (that prove efficacy of the technology) as well as safety studies, for both the insulin and the skin.

Results

All tests performed have been successfully accomplished with results indicating the lack of damage to either the insulin molecule, which maintains its biological function and stability, as seen in vivo, in HPLC studies or in the circular dichroism spectra of the samples, which shows no variability, reaching the characteristic minimum at 219 nm (s.d. ± 8.31) in all groups tested, or to the skin, which suffers none significant damage, as proven by electron microscopy evaluation of the skin or by ELISA and other biochemical assays in which changes in the expression and concentration of relevant skin cellular compounds such as TNF a and IL-2 were studied. Lastly, the technology proved to be effective in the delivery of insulin molecules through the skin in a non-invasive way, as observed in a Franz Diffusion Cell system and in the in vivo model of blood glucose reduction.

Conclusions

Results observed during in vitro and in vivo studies indicate that the technology developed by Medicsen is effective and safe for the patient. Following steps, including human trials, will be critical to fully demonstrate its potential in the treatment of diabetes.