Connected Care for Type 2 Diabetes Self-Management (RCT_SM)

Marche Region Regional Health Agency

Status: Enrolling

Conditions: Diabetes Type 2

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT07149610

4197

Details and patient eligibility

About

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.

Full description

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

Enrollment: 388 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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388 participants in 2 patient groups

Treated group (utilizing m-health solution)

Active Comparator group

Description:

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;

Treatment:

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 group

Description:

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