Actively Recruiting
Connected Care for Type 2 Diabetes: a Study Protocol for a Structured Self-Management Intervention Through Technology and Healthcare Collaboration
Led by Marche Region Regional Health Agency · Updated on 2025-12-31
388
Participants Needed
13
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a mobile health (m-health) solution designed to support self-management skills in adults with Type 2 Diabetes Mellitus (T2DM) living in the Marche region of Italy. This randomized clinical trial compares the use of the personalized m-health tool integrated with the Electronic Patient Record (EPR) against usual diabetes care, focusing on changes in glycated hemoglobin (HbA1c) levels over an 18-month period. The study aims to enhance patients' abilities to manage their condition through technology combined with healthcare collaboration. Participants are randomly assigned to one of two groups: the treated group receives regular care plus access to the m-health solution, while the control group continues with standard care alone. The m-health solution includes mobile apps for tracking health data such as blood sugar, lifestyle habits, and diet, receiving alerts and motivational messages, communicating with healthcare professionals, and accessing educational materials. Healthcare providers will monitor patient data through an integrated platform and communicate as needed. The intervention begins at diabetic centers and continues at participants' homes. Participants will undergo evaluations at the start and at 6, 12, and 18 months, including clinical assessments, questionnaires, and data collected from the m-health solution. Researchers will assess changes in diabetes severity, medication adherence, lifestyle habits, self-efficacy, quality of life, and the usability and satisfaction with the m-health tool. There are no additional visits or lab tests beyond usual care. The study includes cost-effectiveness analysis and gathers participant feedback to understand their experience with the intervention.
CONDITIONS
Brief Title
Connected Care for Type 2 Diabetes Self-Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with Type 2 Diabetes Mellitus by a physician
- Receiving care at one of the 13 Diabetes Centres in the Marche region, Italy
- Aged 18 years or older
- Resident of the Marche region
- HbA1c level above 7% in the last 3 months
- No changes in diabetes medication during the previous 6 months
- Either no hypoglycaemic agents prescribed in the last 4 weeks or stable dose of oral hypoglycaemic agents for more than 12 weeks
- Own a smartphone or mobile phone with internet access
- Able to provide informed consent
- Able to communicate verbally in the local language at a level equivalent to A2 or higher on the CEFR scale
You will not qualify if you...
- Recent acute medical problems such as heart attack or stroke within 6 months
- Physical limitations affecting exercise due to spinal, joint, or neurological conditions
- Severe conditions like advanced Parkinson's disease, advanced dementia, metastatic cancer, or significant sensory impairments
- Uncontrolled hypertension or other serious health issues limiting participation
- Severe depression or other significant psychiatric disorders
- Estimated kidney function below 30 mL/min/1.73 m2
- Planned surgery limiting physical activity during the study
- Pregnancy or breastfeeding
- Participation in other clinical studies
- Lack of written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 18 months
Participants receive either usual care for Type 2 Diabetes Mellitus or usual care plus use a m-health solution integrated with their healthcare system to support self-management of their condition.
Visits with healthcare providers at baseline and at months 6, 12, and 18; ongoing use of mobile applications for monitoring
Trial Site Locations
Total: 13 locations
1
Diabetic Center of Azienda Ospedaliero Universitaria delle Marche
Ancona, Ancona, Italy, 60126
Actively Recruiting
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
Actively Recruiting
3
Diabetic Center of Territorial Healthcare Authority of Ancona province
Fabriano, Ancona, Italy, 60044
Not Yet Recruiting
4
Diabetic Center of Territorial Healthcare Authority of Ancona province
Iesi, Ancona, Italy, 60035
Actively Recruiting
5
Diabetic Center of Territorial Healthcare Authority of Ancona province
Senigallia, Ancona, Italy, 60019
Not Yet Recruiting
6
Diabetic Center of Territorial Healthcare Authority of Ascoli Piceno province
Ascoli Piceno, Ascoli Piceno, Italy, 63100
Not Yet Recruiting
7
Diabetic Center of Territorial Healthcare Authority of Ascoli Piceno province
San Benedetto del Tronto, Ascoli Piceno, Italy, 63074
Actively Recruiting
8
Diabetic Center of Territorial Healthcare Authority of Fermo province
Fermo, Fermo, Italy, 63900
Actively Recruiting
9
Diabetic Center of Territorial Healthcare Authority of Macerata province
Civitanova Marche, Macerata, Italy, 62012
Actively Recruiting
10
Diabetic Center of Territorial Healthcare Authority of Macerata province
Province of Macerata, Macerata, Italy, 62100
Actively Recruiting
11
Diabetic Center of Territorial Healthcare Authority of Pesaro Urbino province
Fano, Pesaro-Urbino, Italy, 61032
Actively Recruiting
12
Diabetic Center of Territorial Healthcare Authority of Pesaro Urbino province
Pesaro, Pesaro-urbino, Italy, 61122
Actively Recruiting
13
Diabetic Center of Territorial Healthcare Authority of Pesaro Urbino province
Urbino, Pesaro-Urbino, Italy, 61029
Not Yet Recruiting
Research Team
P
Project Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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