Connected Care for Type 2 Diabetes Self-Management

NCT07149610 | Recruiting

• 1 other identifier: 4197
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 13

Brief 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

Keywords

self-management; digital solution; Diabete type 2; Chronic diseases; glycated hemoglobin

Outcome Measures

Primary Outcomes (1)

• To improve the SM competencies of patients affected by T2DM living in the Marche region through the support of a m-health solution personalized by the diabetologist and integrated with the EPR of patients.

  This outcome will be assessed through the change in HbA1c levels (%)

  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.

Secondary Outcomes (21)

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

  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 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 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 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 evaluated from baseline to the end of treatment, in details, at month 0, at month 6, at month 12 and at month 18.

Study Arms (2)

Treated group (utilizing m-health solution)

ACTIVE COMPARATOR

The participants assigned to the treated group, in addition to the regular T2DM care, will be provided with a m-health solution to support the SM of T2DM, aimed to improve their SM' skills and abilities. The m-health solution will allow the patients to: 1. track their data, such as glycaemic status, blood pressure, therapy, steps and physical activity, sleep, body weight, laboratory tests (HbA1c, creatinine, cholesterol, etc.); 2. check the target values defined by the diabetologist (e.g., blood glucose, HbA1c, lipid profile, etc.); 3. view their treatment plan; 4. view the diet indicated by the dietitian and record meals/calculate calories/carbohydrates in a simple way (e.g., through list of foods with pictures of dishes and portions); 3\) receive alerts (e.g., therapy reminders) and motivational messages; 4) view summary statistics; 5) communicate with the HCPs through a chat; 6) fill out surveys; 7) access to educational material and technical assistance;

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

Control group (attending usual T2DM care)

NO INTERVENTION

The patients assigned to the control group will receive regular T2DM care according to the Diabetes Association standards

Interventions

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 DEVICE

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.

Treated group (utilizing m-health solution)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with T2DM (as confirmed by the physician's diagnosis);
• belonging to one of the 13 Diabetes Centres (CADs) of the Marche region in Italy (Pesaro, Urbino, Fano, Senigallia, Jesi, Fabriano, IRCCS-INRCA, Azienda Ospedaliera Universitaria delle Marche, Civitanova Marche, Macerata, Fermo, San Benedetto del Tronto e Ascoli Piceno);
• age \> = 18;
• resident in the Marche region;
• HbA1c \> 7 on most recent laboratory report within the last 3 months;
• no changes in diabetes medication in the previous 6 months;
• no prescription for any hypoglycaemic agent within the previous 4 weeks or taking a consistent dose of one or more oral hypoglycaemic agents for more than 12 weeks;
• owning smartphone/mobile phone with an internet connection;
• capable to consent;
• fulfilling and signing the informed consent;
• with self-reported competencies of communicating verbally in local language (corresponding to a level of Italian language knowledge =\>A2 of the CEFR levels).

You may not qualify if:

• acute medical problems: myocardial infarction or stroke within 6 months, difficulty in exercise and physical activity due to spinal disease (intervertebral disc prolapse, spinal stenosis, etc.), joint disease, or major surgery at the time of screening, painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility, advanced Parkinson's disease and/or neuromuscular disorders, advanced dementia, metastatic cancer, in long-term immunosuppressant therapy, significant visual or hearing impairment, uncontrolled hypertension or other serious conditions that restrict their participation in the study, severe/major depression and other relevant psychiatric disorders;
• estimated glomerular filtration rate \< 30 mL/min/1.73 m2;
• plan to receive surgery that could limit physical activity during the study period;
• pregnant or breastfeeding;
• participation in another studies;
• lack of written informed consent.

Sponsors & Collaborators

• Marche Region Regional Health Agency: lead

Study Sites (13)

Diabetic Center of Azienda Ospedaliero Universitaria delle Marche

Ancona, Ancona, 60126, Italy

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, 60127, Italy

RECRUITING

Diabetic Center of Territorial Healthcare Authority of Ancona province

Fabriano, Ancona, 60044, Italy

NOT YET RECRUITING

Diabetic Center of Territorial Healthcare Authority of Ancona province

Iesi, Ancona, 60035, Italy

RECRUITING

Diabetic Center of Territorial Healthcare Authority of Ancona province

Senigallia, Ancona, 60019, Italy

NOT YET RECRUITING

Diabetic Center of Territorial Healthcare Authority of Ascoli Piceno province

Ascoli Piceno, Ascoli Piceno, 63100, Italy

NOT YET RECRUITING

Diabetic Center of Territorial Healthcare Authority of Ascoli Piceno province

San Benedetto del Tronto, Ascoli Piceno, 63074, Italy

RECRUITING

Diabetic Center of Territorial Healthcare Authority of Fermo province

Fermo, Fermo, 63900, Italy

RECRUITING

Diabetic Center of Territorial Healthcare Authority of Macerata province

Civitanova Marche, Macerata, 62012, Italy

RECRUITING

Diabetic Center of Territorial Healthcare Authority of Macerata province

Macerata, Macerata, 62100, Italy

RECRUITING

Diabetic Center of Territorial Healthcare Authority of Pesaro Urbino province

Fano, Pesaro-Urbino, 61032, Italy

RECRUITING

Diabetic Center of Territorial Healthcare Authority of Pesaro Urbino province

Pesaro, Pesaro-urbino, 61122, Italy

RECRUITING

Diabetic Center of Territorial Healthcare Authority of Pesaro Urbino province

Urbino, Pesaro-Urbino, 61029, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Chronic Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Project Manager

CONTACT

+39 071. 8064137; roberta.papa@regione.marche.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicentric, open-label, two-arms randomized controlled trial (RCT) will be conducted to evaluate the improvement of self-management abilities of patients affected by T2DM, after the implementation of the m-health solution (medical device) (treated group), versus usual care (control group). The outcomes assessments will be carried at baseline and at 6, 12 and 18 months.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: September 2, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IT (13)