M-health solution classified as Class I Medical Devices, equipped with a CE certificate. The m-health solution will be integrated with the EPR currently used by the CADs of the Marche region: The m-health solution used in the study includes the following interfaces: 1. for the HCPs of the CADs: * a section of the EPR currently used (Metaclinic), to set the mobile application and to collect clinical data recorded by the patients; * a software to develop and monitor personalised diets (MetaDieta); 2. for the patients: two mobile applications, one for the monitoring of the clinical data and life style (DiaWatch Meteda) and one for the monitoring of the diet (MyDiet), with the latter accessible from a 'button' included in the first one. The HCPs of the CADs, already having access to the EPR Metaclinic, will access a dedicated section for the setting of the target values and goals (e.g., glycaemia, physical activity, etc.) and for the activation of the app DiaWatch Meteda. After the connection of the app with Metaclinic, the data registered in the apps by the patients will be visible by the HCPs in the EPR dashboard.
The primary objective of this Randomized Clinical Trial is to improve the self-management (SM) competencies of patients affected by Type 2 Diabetes Mellitus (T2DM) living in the Marche region (Italy) through the support of a mobile health (m-health) solution personalised by the diabetologist and integrated with the Electronic Patient Record (EPR), assessed through the change in glycated haemoglobin (HbA1c) levels (%) from baseline to the end of the intervention (primary outcome).
Researchers will compare the use of the m-health solution (treated group) to usual T2DM care (control group) in determining change in HbA1c levels (%). The intervention will start at the Diabetic Centres (CADs) where patients are currently followed up and will then take place in each participant's home
Participants of the treated group will:
* receive dedicated training on the use of the m-health solution
* receive the personalization of the m-health solution
* use the m-health solution to: 1) track and view the data related to their health status (e.g., glycaemic status, lifestyle habits, diet) and treatment plane; 2) receive alerts and motivational messages; communicate with the Health Care Professionals (HCPs) of the Diabetic Centre (CAD) in case of need; 3) access to the educational material and to the technical assistance, when needed.
HCPs will be able to monitor the patients' data and clinical parameters and to communicate with the patients. After a baseline evaluation (T0), three follow-up evaluations will be conducted at 4, 8 and 12 months (T1-T2-T3 respectively) , during the usual physician' visits, as part of clinical routine.
The evaluation phases (T0, T1, T2, T3) will be conducted through data derived from: 1) self-administered and paper-based questionnaires, validated in the Italian language; 2) the clinical assessment of patients; 3) the m-health solution, as data automatically derived from the m-health solution; 4) a focus group carried out in a subsample of participants.
Data regarding different health-related areas (T2DM severity; medication adherence; lifestyle habits; self-efficacy related to management of the disease; quality of life), usability of the m-health solution, participants' experience with the intervention, utilization of the m-health solution by the patients, and the cost-effectiveness of the intervention, will be evaluated.
Patients participating in the study will not be required to make any additional visits or undergo any laboratory analysis beyond those specified in their therapeutic plan.
| Facility | City | Region | Status |
|---|---|---|---|
| Diabetic Center of Azienda Ospedaliero Universitaria delle Marche | Ancona | Ancona | Recruiting |
| Diabetic Center of National Institute for the Care and Treatment of the Elderly (Istituto Nazionale di Ricovero e Cura per Anziani-INRCA) | Ancona | Ancona | Recruiting |
| Diabetic Center of Territorial Healthcare Authority of Ancona province | Fabriano | Ancona | Not Yet Recruiting |
| Diabetic Center of Territorial Healthcare Authority of Ancona province | Iesi | Ancona | Recruiting |
| Diabetic Center of Territorial Healthcare Authority of Ascoli Piceno province | Ascoli Piceno | Ascoli Piceno | Not Yet Recruiting |
| Diabetic Center of Territorial Healthcare Authority of Ascoli Piceno province | San Benedetto del Tronto | Ascoli Piceno | Recruiting |
| Diabetic Center of Territorial Healthcare Authority of Fermo province | Fermo | Fermo | Recruiting |
| Diabetic Center of Territorial Healthcare Authority of Macerata province | Civitanova Marche | Macerata | Recruiting |
| Diabetic Center of Territorial Healthcare Authority of Macerata province | Province of Macerata | Macerata | Recruiting |
| Diabetic Center of Territorial Healthcare Authority of Pesaro Urbino province | Fano | Pesaro-Urbino | Recruiting |
| Diabetic Center of Territorial Healthcare Authority of Pesaro Urbino province | Pesaro | Pesaro-urbino | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07149610 on ClinicalTrials.gov ↗ ← All trials in Italy