Connected Care for Type 2 Diabetes Self-Management

1\. Details about recruitment: Prior to the start of the study, the medical directors, the nursing healthcare managers, and nursing coordinators of the CADs involved in the study will be informed about characteristics, methods and aims of the research. The principal investigator (PI) of the study will be responsible to conduct a specific training session on the protocol, the procedures and the data collection to all the HCPs of the CADs participating in the study as staff (e.g., doctors, dietician, nurses), to ensure standardised procedures across all the participating centres and without interfering with clinical-assistance and other priority activities. At the same time, the owners of the mhealth solution will provide specific training on the use of m-health solution, including the interface integrated with the EPR and the mobile app for the patients. In details, the company contact person, in collaboration with the scientific coordinator of the company, will held an in-presence training session of 1 hour for the HCPs, in a dedicated time before the start of the study, to be conducted in small groups, in an interactive way, accepting and answering any doubts. This educational session will include a theorical component, regarding characteristics, functionalities and potentialities of the m-health solution, and a practical component, based on simulations about the use of the m-health solution and about an example of training that will be provided to the participants. The necessity to strengthen and/or supplement the training will be evaluated by the owners of the m-health solution, and, eventually, faced.

The information letter and the paper-based consent form will be delivered by the investigators to the eligible patients, in the CADs of the Marche Region involved in the study, making themselves available for clarifications and explanations. The participants will be enrolled only after having been deeply informed about modalities and principles of data treatment, along with the aims and the characteristics of the study, and only after signing the paper-based informed consent form for the authorization of data processing and for voluntary participation in the study, after a reflection period of 2 weeks. The participants having signed the informed consent to participate in the research will be invited by the investigators, through telephonic calls and/or emails, to consult one of the diabetologist participating as staff in the study. The doctors will carry out the visits to attest the eligibility of the participant for the study, with the support of other HCPs of the CADs, such as nurses, based on the inclusion criteria. The doctor will sign the consent forms too, making him-/her-self available to provide further details and to solve any doubts of the patients. Each signature will be personally dated by each signatory, and the informed consent and any additional patient information will be retained by the investigator. A signed copy of the informed consent and information sheet will be given to each patient. Participants who have signed the consent form but whose inclusion criteria are not confirmed by the doctor will not be included in the study.

2- Legal, ethical and technical considerations:

This study, and, consequently, the data collection, usage and storage procedures, will be conducted according to the principles expressed in:

* The Declaration of Helsinki 2024 * the standards of Good Clinical Practice * the Legislative Decree no. 196/03 Italian Personal Data Protection Code * EU General Data Protection Regulation 2016 * Legislative Decree No. 101/2018 on Provisions for the adaptation of national legislation to the provisions of European Regulation 2016/679 * Guidelines for the collection of informed consent for participation in clinical trials, National Coordination Centre for Ethics Committees.

The study will start only after notification and acknowledgement by the Regional Ethics Committee and the completion of the administrative requirements of the institution where the study is being conducted. No sponsorship is envisaged for the conduction of this study

• To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits. [Срок оценки: This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 6, at month 12 and at month 18.]
• To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits. [Срок оценки: This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 6, at month 12 and at month 18.]
• To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits. [Срок оценки: This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 6, at month 12 and at month 18.]
• To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits. [Срок оценки: This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 12 and at month 18.]
• To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits. [Срок оценки: This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 6, at month 12 and at month 18.]
• To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits. [Срок оценки: This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 6, at month 12 and at month 18.]
• To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits. [Срок оценки: This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 6, at month 12 and at month 18.]
• To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits. [Срок оценки: This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 6, at month 12 and at month 18.]
• To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits. [Срок оценки: This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 6, at month 12 and at month 18.]
• To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits. [Срок оценки: This outcome will be evaluated from HADs, at baseline (month 0) and at the the end of treatment (namely at month 18).]
• To evaluate the changes, after the intervention, in the levels of medication adherence [Срок оценки: This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 6, at month 12 and at month 18.]
• To evaluate the changes, after the intervention, in dietary and alcohol consumption habits [Срок оценки: This outcome will be evaluated from baseline to the end of treatment, in details, at month 0, at month 6, at month 12 and at month 18.]