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

Connected Care for Type 2 Diabetes: a Study Protocol for a Structured Self-Management Intervention Through Technology and Healthcare Collaboration

Not applicable Interventional Marche Region Regional Health Agency · NCT07149610

This project will see if a personalized mobile app linked to your clinic's electronic record helps adults with type 2 diabetes in the Marche region lower their HbA1c compared with usual care.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment388 (estimated)
Ages18 Years and up
SexAll
SponsorMarche Region Regional Health Agency Academic / other
Locations13 sites (Ancona, Ancona and 12 other locations)
Trial IDNCT07149610 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal participants are adults (≥18) living in the Marche region, followed at one of the participating CADs, with HbA1c >7, stable diabetes medication, and a smartphone with internet access.

Not a fit: Patients without a smartphone, not resident in the Marche region, with HbA1c ≤7, recent medication changes, or who cannot use the app are unlikely to benefit.

Why it matters

Potential benefit: If effective, this approach could improve day-to-day self-management and reduce HbA1c, potentially lowering the risk of diabetes complications.

How similar studies have performed: Prior digital self-management programs for type 2 diabetes have produced modest HbA1c improvements, but solutions tightly integrated with local EPRs are less commonly tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Ancona, Ancona and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetes Type 2self-managementdigital solutionDiabete type 2Chronic diseasesglycated hemoglobin
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.