Connected care to manage type 2 diabetes with a personalized mobile app

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial will compare a personalized m-health solution integrated with the regional electronic patient record (EPR) to usual care for adults with type 2 diabetes followed at Diabetes Centres (CADs) in the Marche region. Participants randomized to the intervention will receive training, have the app personalized by their diabetologist, and use the app at home to track self-management tasks while data syncs with the EPR. The primary outcome is change in glycated hemoglobin (HbA1c) from baseline to the end of the intervention, with data collected at participating CADs and through the app. Recruitment focuses on adults with HbA1c >7 who own a smartphone and have stable diabetes medication, and staff at participating centers receive standardized training to ensure consistent implementation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Diabetic Center of Azienda Ospedaliero Universitaria delle Marche
  Ancona, Ancona, 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, Italy Recruiting
• Diabetic Center of Territorial Healthcare Authority of Ancona province
  Iesi, Ancona, Italy Recruiting
• Diabetic Center of Territorial Healthcare Authority of Ascoli Piceno province
  San Benedetto del Tronto, Ascoli Piceno, Italy Recruiting
• Diabetic Center of Territorial Healthcare Authority of Fermo province
  Fermo, Fermo, Italy Recruiting
• Diabetic Center of Territorial Healthcare Authority of Macerata province
  Civitanova Marche, Macerata, Italy Recruiting

Study contacts

• Study coordinator: Project Manager
• Email: roberta.papa@regione.marche.it
• Phone: +39 071. 8064137

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.