Andellini, Martina http://orcid.org/0000-0002-2931-0753
Haleem, Salman
Angelini, Massimiliano
Ritrovato, Matteo
Schiaffini, Riccardo
Iadanza, Ernesto
Pecchia, Leandro
Funding for this research was provided by:
Wellcome Trust (WT-219429/Z/19/Z)
Article History
Received: 25 November 2022
Revised: 25 November 2022
Accepted: 20 December 2022
First Online: 23 January 2023
Statements & declarations
:
: The authors declare that they have no competing interests.
: The study protocol adheres to the ethical principles stated in the Declaration of Helsinki and the National Health and Medical Research Council statement and was approved by the Ethical Committee of Bambino Gesù Children’s Hospital, Rome, Italy (2260_OPBG_2020).
: All participants and their parents or caregivers will be required to fill in a written consent form, where the methods, advantages and disadvantages in taking part to the experiment will be explained. The study participation will not impose any risks for patients and will not affect in any way the clinical path of the recruited patients, as they will continue to receive their usual diabetes care, and they will continue to manage diabetes as usual. The trial is registered in the clinicaltrial.gov registry (ID: NCT03936634) and will be performed in accordance with the approved guidelines and regulations of the institution.
: Not applicable.