A novel decision aid tool for optimal levothyroxine dosage after total thyroidectomy

Finding the right dosage of the drug Levothyroxine for patients that has surgically removed the Thyroid gland (called thyroidectomy) takes several months in today's clinical standard. Patients who are going through such a dose adjustment, experience reduced quality of life and long periods of sick leave is often nesseccary. Inventors from UNN and Sintef have developed a decision aid tool which models how levothyroxine is behaving and metabolised in individual patients based on early blood samples. In a prospective randomised multi-centre study, more patients reached their target and ended dose adjustment in eight weeks when the tool was used, compared with the control group. Our team has received funding from Health North innovation to test the decision tool in a patient centred pilot study. The documentation from that trial will be crucial for further regulatory approval for our decision aid tool. Alongside with this clinical trial, we need to make a strategy for the commercialization and implementation of this health information technology. Digital health solutions, and health apps in particular, holds tremendous potential for improving health outcomes. But for apps to be used and integrated into clinical practice, there are several key areas that need to be addressed, like regulatory issues, digital formularies and user interface, education and workflow integration, payments models and patient/provider support. Our goal is to launch this tool within 2026 for use on patients that has undergone thyroidectomy.

During the project we have focused on getting external expertise to consult us regarding classification of the technology according to the MDR requirements and also perform a GAP analysis of the exsisting documentation compared to the MDR requiements in a future CE-certification of the technology. We have also progressed some intial industry discussion regarding the commercialisation, however these have not been concluded. The identified gaps in the regulatory work is pivotal to adress in the commercialisation and will form the basis for a Proof of Concept application to an upcoming NRC call.