Connected Care for Type 2 Diabetes Self-Management

To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.

This outcome will be assessed evaluating the change in the level of fasting glucose (mg/dl)

Time frame: 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.

This outcome will be assessed evaluating the change in glycaemic variability/capillary blood glucose monitoring, when foreseen by patients' therapeutic plan

Time frame: 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.

This outcome will be assessed evaluating the change in the levels of Serum total cholesterol (mg/dl), triglycerides (mg/dl), High-Density Lipoproteins (mg/dl) and Low-Density Lipoproteins cholesterol (mg/dl).

Time frame: 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.

This outcome will be assessed evaluating the change in Microalbuminuria levels (mg/dl).

Time frame: 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.

This outcome will be assessed evaluating the change in waist circumference (cm)

Time frame: 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.

This outcome will be assessed through evaluating the body weight (kg).

Time frame: 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.

This outcome will be assessed evaluating the change Body Mass Index (BMI) (kg/m\^2).

Time frame: 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.

This outcome will be assessed evaluating the change in blood pressure's values (mmHg);

Time frame: 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.

This outcome will be assessed evaluating changes regarding the following anamnestic measurements: comorbidities, medications and complications related to T2DM, including the number of hypoglycaemia and hyperglycaemia episodes in the last 6 months.

Time frame: 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.

This outcome will be assessed evaluating the number of unscheduled hospital visits due to hypoglycaemia or hyperglycaemia within 12 months: outcome assessed retrospectively through the Administrative Healthcare Databases (HADs) of Hospital discharge records occurred in public and private hospitals and Emergency and Urgency care according to ICD-9 codes (250.3, 250.8, 251.0, 251.1, 251.2, 270.3, 790.6).

Time frame: 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

This outcome will be assessed through the "Medication Adherence Report Scale- MARS-5 ©", validated in Italy, composed by five questions on both unintentional and intentional non-adherence, namely forgetting, changing dosage, stopping, skipping and taking less medication. The score ranges from 5 to 25, where a higher score indicates higher self-reported adherence.

Time frame: 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

This outcome will be assessed through the questionnaire "Literature Based Adherence Score to Mediterranean Diet- MEDILITE", that enables the user to ascertain their consumption of 9 food categories, defined in scientific studies examining the correlation between adherence to the Mediterranean diet and health outcomes. The 9 food groups are: fruits; vegetables; cereals; legumes; fish; meat and meat products; dairy products; alcohol; olive oil. The scores assigned differ for each item: typical foods of the Mediterranean diet (2=highest consumption category; 1=intermediate category; 0=lowest category); non-typical foods (2=lowest intake; 1=intermediate intake; 0=highest consumption); alcohol (2=1-2 alcohol units/day; 1=1 alcohol unit/day; 0= \>2 alcohol units/day); olive oil (2=regular use; 1=frequent use; 0=occasional use). The final score, obtained from the sum of all these scores, ranges from 0 (low adherence to the Mediterranean diet) to 18 (high adherence).

Time frame: 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 smoking habits

This outcome will be assessed through n. 11 ad hoc questions to analyse the smoking habits and history, elaborated from the questions included in the EPR of patients (routinely collected) and from the National Institute of Statistics-ISTAT questionnaires.

Time frame: 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 levels of physical activity

This outcome will be assessed through the "International Physical Activity Questionnaire- Short Form- IPAQ-SF": validated in Italian language, evaluates frequency (days per week) and duration (minutes per day) of three types of activity, i.e., walking, moderate intensity and vigorous intensity activities. The scale assigns a score to each activity and a total score, calculated from the duration and frequency of three activities. Activity volume can also be expressed in MET-minutes (METs x minutes x frequency per week). Scores can be continuous or categorized: 1. Low - below moderate or high criteria; 2. Moderate - e.g., 3+ days of vigorous activity (20+ min/day), or 5+ days of moderate/walking (30+ min/day), or 600+ MET-min/week; 3. High - 3+ days vigorous activity totaling 1500+ MET-min/week, or 7+ days of mixed activity reaching 3000+ MET-min/week.

Time frame: 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 the levels of self-efficacy perceived by partecipants

This outcome will be assessed through the "The Italian Diabetes Management Self-Efficacy Scale- IT-DMSES", that consists of 15 items divided into two factors of self-efficacy in diabetes management: 1) self-perception of patient's ability to manage the activities related to diabetes management (e.g., medication adherence, Glycaemic Control), and 2) self-efficacy in lifestyle management (e.g., eating behaviours, physical activities). Scores per factor range from 0 to 10, indicating low (0-3), mid (4-6), and high (7-10) levels of self-efficacy.

Time frame: 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 the levels of quality of life perceived by partecipants

This outcome will be assessed through the scale "EuroQol 5-digit 5-level Visual Analogue Scale- EQ-5D-5L VAS", validated in Italian language, in details through its descriptive system, consisting on five dimensions: mobility, independence, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no/mild/moderate/severe/extreme problems. The participant is asked to indicate his/her health status with the most appropriate statement in each of the five dimensions, producing also a 5-digit number that describes the health profile of the participant.

Time frame: 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 the levels of quality of life perceived by partecipants

This outcome will be assessed through the scale "EuroQol 5-digit 5-level Visual Analogue Scale- EQ-5D-5L VAS", validated in Italian language, in details through the EQ VAS part, represented in a vertical scale from 0 to 100 in 5-point increments. The participant is asked to represent his/her health status putting a cross on the scale, then translated into an integer between 0 and 100.

Time frame: 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 collect information regarding participants' perception of usability of the m-health solution, their level of satisfaction and any benefits they have experienced.

This outcome will be through the Italian version of the System Usability Scale-SUS" , a ten-item tool giving a global view of subjective assessments of usability. The response options are based on the Likert scale, from 1= strong disagreement; to 5= strong agreement, for a total score ranging from 0 to 100, to be evaluated based on a computation table.

Time frame: This outcome will be evaluated at month 6, at month 12 and at the end of the intervention (namely at month 18).

To collect information regarding participants' experience with the intervention.

This outcome will be assessed through focus groupm carried out in a subsample of participants (max 5-10 participants for each focus group) to gain additional insights on the patient's experience with the intervention, that will allow patients to discuss about perceptions and opinions about the utility of the intervention and of the m-health solution, letting patients free to express their ideas and suggestions. The focus group will be carried out by two experienced researchers from the research team: 1) the moderator, acting as initiator and facilitator of the discussion, as well as mediating between participants and conducting discussion through posing main questions; 2) the observer/note-taker, acting as rapporteur, writing down notes about both discussion between participants (e.g., topics covered, opinions emerging, contrasts, new issues). The discussion will be audio recorded and transcribed verbatim to facilitate subsequent analysis and reporting.

Time frame: This outcome will be evaluated at the end of the intervention, namely at month 18

To collect information regarding the utilization of the m-health solution by the patients

This outcome will assessed through data analytics collected by the digital system as utilization measures automatically derived from the mobile apps used by the patients, namely, number of accesses, time of use, and frequency of use of the key features such as inputs of data, access to training/information documents, chat, and consultation of target values and treatment plan. The data collected will be processed to produce periodic reports highlighting areas of increased use, any critical issues, and suggestions for future improvements.

Time frame: This outcome will be evaluated at month 6, at month 12 and at the end of treatment, namely at month18

To evaluate the cost-effectiveness of the intervention.

This outcome will be assessed through Incremental Cost-Effectiveness Ratio (ICER), that will be calculated as the difference in costs divided by the difference in health benefits over an 18-month period from a healthcare sector perspective. A bottom-up micro-costing approach will assess all individual-level costs for control and intervention groups, including diabetes care (hospital admissions, emergency care, outpatient visits, lab tests, drugs, consumables). The intervention group also includes technology-related costs (software, maintenance). The evaluation is within-trial. Cost-effectiveness is based on HbA1c; QALYs, derived from EQ-5D-5L, are used for cost-utility analysis. ICERs will be reported with 95% confidence intervals via bootstrapping. A €25,000-€60,000 per QALY threshold and sensitivity analyses with acceptability curves will assess uncertainty.

Time frame: This outcome will be evaluated at the end of the intervention, namely at 18 months