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Study identifier: NCT07149610 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Connected Care for Type 2 Diabetes Self-Management

Condition: Diabetes Type 2  ·  Sponsor: Marche Region Regional Health Agency

PhaseNA
Planned participants388
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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-u…

This description comes directly from the study's public registry record.

Talk to the study team

Project Manager  ·  +39 071. 8064137  ·  roberta.papa@regione.marche.it

Always discuss trial participation with your own doctor first.

Locations (13)

Diabetic Center of Azienda Ospedaliero Universitaria delle MarcheAncona, Ancona, ItalyRecruiting
Diabetic Center of National Institute for the Care and Treatment of the Elderly (Istituto Nazionale di Ricovero e Cura per Anziani-INRCA)Ancona, Ancona, ItalyRecruiting
Diabetic Center of Territorial Healthcare Authority of Ancona provinceFabriano, Ancona, ItalyNot Yet Recruiting
Diabetic Center of Territorial Healthcare Authority of Ancona provinceIesi, Ancona, ItalyRecruiting
Diabetic Center of Territorial Healthcare Authority of Ancona provinceSenigallia, Ancona, ItalyNot Yet Recruiting
Diabetic Center of Territorial Healthcare Authority of Ascoli Piceno provinceAscoli Piceno, Ascoli Piceno, ItalyNot Yet Recruiting
Diabetic Center of Territorial Healthcare Authority of Ascoli Piceno provinceSan Benedetto del Tronto, Ascoli Piceno, ItalyRecruiting
Diabetic Center of Territorial Healthcare Authority of Fermo provinceFermo, Fermo, ItalyRecruiting
Diabetic Center of Territorial Healthcare Authority of Macerata provinceCivitanova Marche, Macerata, ItalyRecruiting
Diabetic Center of Territorial Healthcare Authority of Macerata provinceProvince of Macerata, Macerata, ItalyRecruiting
Diabetic Center of Territorial Healthcare Authority of Pesaro Urbino provinceFano, Pesaro-Urbino, ItalyRecruiting
Diabetic Center of Territorial Healthcare Authority of Pesaro Urbino provincePesaro, Pesaro-urbino, ItalyRecruiting

+ 1 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07149610