Document is current

Article History

Received: 30 October 2019

Accepted: 22 October 2020

First Online: 23 November 2020

Ethics approval and consent to participate

: The principal investigator (XL), who is a diabetologist, will introduce the details of the trial to patients during a face-to-face appointment. A hardcopy of the information leaflet will be provided to the patients. Each informed patient will then discuss his/her possible enrollment with the principal investigator if necessary. Formal written informed consent will be obtained from each eligible patient who is willing to participate in the trial. On the consent form, participants will be asked for permission to use their data and to share their data with research personnel relevant to the trial. Additionally, participants will be notified that they are free to withdraw from the trial at any time. Moreover, this trial does not involve collecting biological specimens for storage. There is no anticipated harm or compensation associated with trial participation.Hardcopies of the trial-related documents will be stored securely with restricted access. Patients’ identifying information will be replaced with depersonalized codes in the electronic database. All softcopy files will be encrypted and password-protected, with only authorized research staff having access to the electronic data sets and hardcopy documents.The trial has been approved by the Ethics Committee of the Second Xiangya Hospital, Central South University (2019 Ethics Approval [Department] No. 072). A checklist of Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) is available in Additional file InternalRef removedand a full SPIRIT figure is shown in Fig. InternalRef removed. The results of the trial will be published in peer-reviewed publications and conference presentations.

: Not applicable.

: The authors declare that they have no competing interests.