Zoccarato, Francesca
Manzoni, Martina
Minotti, Davide
Lettieri, Emanuele
Boaretto, Andrea
Funding for this research was provided by:
Roche Diabetes Care Italy Spa
Article History
Received: 6 March 2024
Accepted: 12 June 2024
First Online: 18 June 2024
Declarations
:
: This study has been fully performed in accordance with guidelines and regulations. The study did not require to pass through approval from an ethics committee because this study did not change in any way patients’ therapy plans, as stated by the Decree of the Minister of Health dated February 1, 2022, and by the Regulations of the “National Ethics Committee for trials of public research institutions (EPRs) and other public institutions of national character,” at the Istituto Superiore di Sanità (ISS). Such laws state that ethic committee approval is required in the following circumstances: evaluation of clinical trials under EU Regulation 536/2014 carried out by ISS, EPRs and other public bodies of national character; evaluation of protocols of other studies (including clinical, observational, diagnostic, public health, with medical devices, with the use of human biological material, with environmental ethics implications) carried out by ISS and, possibly, by other EPRs and public bodies of national character; Advice and expression of opinions on ethical aspects of activities and interventions of ISS, in relation to its functions and duties as defined by the Statute of ISS, the Rules of Organization and Operation of ISS, and in compliance with applicable regulations.In the current paper, instead, patients were involved in this study just to express their anonymous opinions about CGM. Patients were recruited by their doctors and nurses who informed them of the purpose of this study and the policy for data collection, processing, and communication (aggregated and anonymously) coherently to the GDPR indications.Participants expressed their acceptance through an informed consent form about the usage of the collected data with the research team. Participants were also explicitly asked to accept the conditions regarding the data used for this study.
: Not applicable.
: The authors declare no competing interests.