Connected Care for Type 2 Diabetes Self-Management

Summary

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 6, 12 and 18 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.

Conditions

• Diabetes Type 2

Interventions

DEVICE

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.

Sponsors & Collaborators

• Marche Region Regional Health Agency

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-13

Primary Completion

2026-11-30

Completion

2026-12-31

Countries

• Italy

Study Locations