Status:
RECRUITING
Connected Care for Type 2 Diabetes Self-Management
Lead Sponsor:
Marche Region Regional Health Agency
Conditions:
Diabetes Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
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) ...
Detailed 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 abou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT07149610
Start Date
October 13 2025
End Date
December 31 2026
Last Update
December 31 2025
Active Locations (13)
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1
Diabetic Center of Azienda Ospedaliero Universitaria delle Marche
Ancona, Ancona, Italy, 60126
2
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, 60127
3
Diabetic Center of Territorial Healthcare Authority of Ancona province
Fabriano, Ancona, Italy, 60044
4
Diabetic Center of Territorial Healthcare Authority of Ancona province
Iesi, Ancona, Italy, 60035