Research claims:
In case of bolus administration, even the most recent automated systems cannot react to the quick variations of glucose due to food ingestion or to changes in the kinetics of insulin absorption.Skin alterations, such as lipo-hypertrophic nodules, are the main causes of intra-individual variability in insulin absorption.An accurate insulin bolus administration is guaranteed only by a real-time monitoring of the amount of insulin actually absorbed, namely bioavailable.
Therefore, the main claim of research is to develop an insulin bioavailability assessment system:
- non-invasive;
- real-time;
Estimating the insulin absorption trend provides a sound basis for personalized diabetic therapies in different clinical condition.
Method:
- The insulin bioavailability over time is assessed indirectly from the measurement of its time dependent disappearance from the administration site;
- This insulin variation is assessed noninvasively by spectroscopy impedance measurements;
- During administration phase, an insulin_appearance/impedance_variationmodel is identified (personalized medicine);
- The personalized model is metrologicallycharacterized in order to assess the reproducibility, resolution, sensitivity.
- The model is used to estimate insulin disappearance i.e. absorption.
Research Results:
An on chip instrument for insulin absorption measurement was prototyped.
A metrological characterizationin vitro on dried eggplants, ex vivo on pig abdominal non-perfused muscle, and preliminaryin vivo on a human subject were realized.
The micro-instrument shows:
- a linear relationship between the variation of impedance and the insulin decrease;
- in in-vitro experiments a sensitivity of 497.3 ml-1, a non-linearity of 4.0 %, a 1-σ repeatabilily mean of 1.3 % and a reproducibility of 1.9 %;
- inex-vivo experiments shows a sensitivity of 157.2 ml-1, a non-linearity of 2.1 %, a 1-σ repeatabilily mean of 1.6 % and a reproducibility of 2.4 %.
Development:
Clinical study
The study will enroll 25 patients with diabetes mellitus type 1, already undergoing diabetic therapy at Diabetology Center of AOU Policlinico Federico II for:
- Insulin bioavailability monitoring after bolus injection;
- Continuous Real time monitoring of insulin bioavailability for personalized therapy (Holter solution).
Key selling points:
- Portable system
- Real time
- Non-invasive measurement
- Drug absorption assessment
Stakeholders:
- Electromedical Devices Industry
- Diabetic Patients
- Healthcare Sector