An observational study in Type 2 Diabetes and Diabete Mellitus, sponsored by Marche Region Regional Health Agency. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Marche Region Regional Health Agency · Observational
Among 420 studies in Diabetes Mellitus, Type 2 with a site in Italy — 45 open to participants now, 61 under way, 11 of them phase 3. Diabetes Mellitus, Type 2 · Italy.
Among the 420 studies in Diabetes Mellitus, Type 2 with a site in Italy, this one is the 86th largest by planned enrollment of the 99 observational ones that give a count, is one of 13 that started in 2025, is one of 99 observational ones, reaches primary completion later than 29 of the 60 other live ones, and was the 414th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →45 of the 420 studies in Diabetes Mellitus, Type 2 with a site in Italy are open now. Recruiting first, the newest first:
Novo Nordisk A/S · Sites in Italy, United States, Argentina and 13 more countries
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Eli Lilly and Company · Sites in Italy, United States, Belgium and 8 more countries
AstraZeneca · Sites in Italy, United States, Argentina and 12 more countries
Pfizer · Sites in Italy, United States, Brazil and 8 more countries
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
420 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 44 · Phase 3 156 · Phase 4 54
First in 1997; this study’s year is marked. 13 started in 2025.
This study's planned enrollment of 50 is below the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 319 across the 320 interventional studies, 500 across the 99 observational. Of the 316 that completed or were terminated, 132 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
226 of 420 have an industry lead sponsor. The 10 most frequent:
Marche Region Regional Health Agency is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Marche Region Regional Health Agency has 3 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
12 of the studies in Diabetes Mellitus, Type 2 with a site in Italy that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06858878Phase 3AmgenEfficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT07149610Marche Region Regional Health AgencyConnected Care for Type 2 Diabetes Self-Management | 2026-11-30 |
| NCT03604198Corcept TherapeuticsExtension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | 2026-12 |
| NCT07783893Marche Region Regional Health AgencyE-Health Literacy Intervention for Bangladeshi Migrants With Type 2 Diabetes in Italy | 2026-12 |
| NCT05759637Istituto Auxologico ItalianoType 2 Diabetes, Obesity and Cortisol Excess | 2026-12-31 |
Among the 420 studies in Diabetes Mellitus, Type 2 with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is testing a training program for people from the Bangladeshi community of Ancona in the Marche Region (Italy) who have type 2 diabetes. Many people in this group find it hard to understand health information, including how to use digital health tools. This is called low health literacy. Low health literacy can make it harder to manage diabetes well.
The goal of this study is to find out if the training program improves health literacy and confidence in managing diabetes.
About 50 adults with type 2 diabetes from the Bangladeshi community are taking part. They are followed by the diabetes clinic at the University Hospital of the Marche Region in Ancona.
Before training started, patients, caregivers, and health workers helped design the program together. This made sure the training fit the community's needs and culture.
Participants complete a training program with four short modules. The modules cover diabetes, health literacy, and digital skills for managing diabetes.
Researchers measure health literacy, digital skills, and confidence in managing diabetes before training, right after training, and again after 1 month and 6 months. This shows whether the improvements last over time.
This study is part of JACARDI, a European project working to reduce diabetes and heart disease across Europe.
This is a monocentric pilot study conducted within the JACARDI (Joint Action on CARdiovascular diseases and Diabetes) framework, Grant Agreement ID 101126953, whose general objective is to reduce the burden of cardiovascular disease and diabetes across EU countries by integrating validated best practices through transnational pilot initiatives. The study is led by the Regional Health Agency of the Marche Region (Italy), in collaboration with the diabetes center (Centro Antidiabetico, CAD) of the University Hospital of the Marche Region (Azienda Ospedaliero-Universitaria delle Marche) in Ancona.
Type 2 diabetes mellitus (DM) is a growing global health burden, and glycaemic control is a central therapeutic goal that depends heavily on patients' self-management abilities. Self-management capacity, in turn, is strongly related to individual health literacy (HL) - the ability to obtain, process, and understand basic health information - and eHealth literacy (e-HL), the ability to find, evaluate, and apply electronic health information to health problems. People with low HL and e-HL tend to have poorer health outcomes, higher hospitalization and mortality rates, and reduced ability to self-manage chronic conditions. These risks are amplified in ethnic minority populations facing linguistic and social barriers. The Bangladeshi community is one of the largest foreign populations in the Marche Region and, as part of the Asian population, is at elevated risk of type 2 DM as well as low HL and e-HL. Evidence indicates that structured, culturally oriented educational programs, delivered by trained healthcare professionals and involving peer support, are effective in improving self-management and glycaemic control, and that early, sustained involvement of stakeholders in intervention design improves implementation outcomes and long-term sustainability.
The study follows the OPHELIA (OPtimising HEalth Literacy and Access) methodology, which combines local community engagement with international evidence to co-design, develop, and implement health literacy interventions that are accessible, culturally appropriate, and sustainable. The study is structured in two main phases: a pre-study (co-design) phase and a core intervention phase.
The pre-study phase involves a situation analysis conducted using the Consolidated Framework for Implementation Research (CFIR) and PESTEL (Political, Economic, Social, Technological, Environmental, Legal) tools to identify enablers of and barriers to implementation, through one online and one in-person stakeholder meeting; and two focus groups with patients and their family/community members supported by a cultural mediator, to assess healthcare service accessibility, evaluate the appropriateness of the planned training content, and gather input on perceived barriers and enablers to using digital health tools. These focus groups used co-design techniques and were analyzed qualitatively. Educational materials - brochures and digital tools including videos - were developed drawing on the ACCESS training program, materials used in clinical routine, and validated guidelines from the Ministry of Health and diabetes scientific societies, then translated and culturally adapted into Italian and Bengali and made available to participants.
Approximately 50 participants are organized into 4 training sessions of 10 participants each. Each session comprises 4 modules delivered in person at the CAD of Ancona, combining didactic and interactive methods, with support from a cultural mediator and diabetic peers:
Module I: Awareness of DM type II, and core principles of HL and e-HL Module II: Digital health skills, part I - use of health apps and digital tools Module III: Digital health skills, part II - usability of technological devices and online health services Module IV: Self-evaluation of acquired knowledge and skills, and assessment of program sustainability and satisfaction
Data are collected at four time points - baseline (T0, before training), post-intervention (T1, at the end of the training), 1-month follow-up (T2), and 6-month follow-up (T3) - using validated, self-administered, paper-based questionnaires, together with clinical assessment. Assessed domains include eHealth literacy, health literacy, self-efficacy in diabetes management, social integration and support, quality of life, DM severity and related clinical parameters, diabetes-related emotional distress, and participants' perceived satisfaction with the training.
Continuous variables are reported as mean and standard deviation or median and interquartile range depending on distribution (assessed via Kolmogorov-Smirnov test); categorical variables as absolute numbers and percentages. Pre- and post-intervention comparisons use paired t-tests or Wilcoxon matched-pairs signed-rank tests for continuous outcomes, and Mann-Whitney U or Chi-square tests as appropriate. Analyses are performed using STATA or R.
This study poses minimal risk to participants. Personal data are processed in anonymous, aggregate form in accordance with EU Regulation 2016/679 (GDPR) and Italian Legislative Decree No. 101/2018.
Adults of Bangladeshi ethnicity with type 2 diabetes mellitus, residing in the Marche Region (Italy) and followed by the diabetes center (Centro Antidiabetico, CAD) of the University Hospital of the Marche Region (Azienda Ospedaliero-Universitaria delle Marche) in Ancona. Participants are recruited from among patients already in active follow-up at this clinic who wish to take part in the study and meet the eligibility criteria, including sufficient Italian language proficiency (CEFR level A2 or above), preserved cognitive status, absence of severe depressive symptoms, and low levels of health literacy, eHealth literacy, or self-efficacy in diabetes management. The Bangladeshi community is one of the largest ethnic minority groups in the Marche Region.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults of Bangladeshi ethnicity with type 2 diabetes mellitus, followed by the diabetes center (CAD) of the University Hospital of the Marche Region in Ancona, meeting the study eligibility criteria. Participants receive a culturally adapted health literacy and eHealth literacy training intervention, co-designed with patients, family/community members, and healthcare stakeholders during a preparatory phase. The intervention consists of 4 modules delivered in person over 8 weeks (1 module every 15 days, approximately 120 minutes each), combining didactic and interactive methods with the support of a cultural mediator and diabetic peers. Modules cover: awareness of type 2 diabetes, health literacy and eHealth literacy principles; digital health tools and apps; usability of technological devices and online health services; and self-evaluation of acquired skills. Outcomes are assessed at baseline, post-intervention, and at 1- and 6-month follow-up.
Behavioral: Culturally Adapted eHealth Literacy Training Program
A structured, culturally adapted educational intervention aimed at improving eHealth literacy, health literacy, and self-management skills in Bangladeshi patients with type 2 diabetes. The training was co-designed with patients, family/community members, and healthcare stakeholders during a preparatory phase, based on the OPHELIA methodology and the ACCESS training model. It consists of 4 modules delivered in person at the diabetes center over 8 weeks (1 module every 15 days, approximately 120 minutes each), combining didactic teaching and interactive/practical sessions, with the support of a cultural mediator and diabetic peers. Topics include: type 2 diabetes awareness and management; principles of health literacy and eHealth literacy; use of digital health apps and tools; usability of technological devices and online health services; and self-evaluation of acquired knowledge and skills.
Improvement of ehealth literacy among Bangladeshi type 2 diabetes patients
eHealth literacy will be assessed using the eHealth Literacy Scale (eHEALS), an 8-item measure of consumers' combined knowledge, comfort, and perceived skills in finding, evaluating, and applying electronic health information to health problems. The scale assesses the ability to access and use internet health information (items 1-5), judgment ability (items 6-7), and decision-making ability (item 8). Each item is rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with total scores ranging from 8 to 40; higher scores indicate greater eHealth literacy. The scale will be administered as a self-reported, paper-based tool, with support from a cultural mediator when needed, at baseline, at the end of the training intervention, and at 1-month and 6-month follow-up.
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Improvement of health literacy levels among paticipants
Health literacy will be assessed using the 16-item European Health Literacy Survey Questionnaire (HLS-EU-Q16), which measures health literacy across three domains: healthcare, disease prevention, and health promotion. Each item is answered by choosing one of four response options: "very difficult," "fairly difficult," "fairly easy," or "very easy." The questionnaire will be administered as a self-reported, paper-based tool, with support from a cultural mediator when needed, at baseline, at the end of the training intervention, and at 1-month and 6-month follow-up, to evaluate change over time.
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Improvement of Self-Efficacy in Diabetes Management (IT-DMSES)
Self-efficacy in diabetes management will be assessed using the Italian Diabetes Management Self-Efficacy Scale (IT-DMSES). The scale consists of 15 items divided into two factors: Factor 1, self-efficacy in diabetes management (e.g., medication adherence, glycaemic control), and Factor 2, self-efficacy in lifestyle management (e.g., eating behaviors, physical activity). Each factor score ranges from 0 to 10, with higher scores indicating greater self-efficacy (low: 0-3; mid: 4-6; high: 7-10). The scale will be administered as a self-reported, paper-based questionnaire, with support from a cultural mediator when needed, at baseline, at the end of the training intervention, and at 1-month and 6-month follow-up, to evaluate change over time.
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Improvement of Perceived Social Support and Integration (MSPSS)
Perceived social support and integration will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS), a 12-item self-reported questionnaire measuring perceived adequacy of social support from three sources: family, friends, and significant others. Each item is rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 5 (strongly agree). The questionnaire will be administered as a self-reported, paper-based tool, with support from a cultural mediator when needed, at baseline and at 1-month follow-up, to evaluate change over time.
Time frame: Baseline (T0) and 1-month follow-up (T2)
Improvement of Quality of Life (EQ-5D-5L VAS)
Quality of life will be assessed using the EQ-5D-5L Visual Analogue Scale (VAS). The EQ-5D-5L consists of five dimensions - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression - each rated across 5 severity levels (no problems, slight, moderate, severe, extreme problems). Participants indicate their health status by selecting the most appropriate level for each dimension, and additionally rate their overall health on the VAS, a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health). The questionnaire will be administered as a self-reported, paper-based tool, with support from a cultural mediator when needed, at baseline, at the end of the training intervention, and at 1-month and 6-month follow-up, to evaluate change over time.
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Reduction of Diabetes-Related Emotional Distress (PAID)
Diabetes-related emotional distress will be assessed using the Problem Areas in Diabetes (PAID) questionnaire, a 20-item self-report scale measuring negative emotions related to diabetes (e.g., fear, anger, frustration). Each item is rated on a 5-point scale from 0 ("no problem") to 4 ("a serious problem"). The questionnaire will be administered as a self-reported, paper-based tool, with support from a cultural mediator when needed, at baseline, at the end of the training intervention, and at 1-month and 6-month follow-up, to evaluate change over time.
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Perceived utility, efficacy and effectiveness of the training (ad hoc questionnaire)
Participants' experience with the training will be assessed using an ad hoc, self-reported questionnaire developed specifically for this study, based on the target group and training modules. The questionnaire collects information on participants' overall satisfaction, perceived usefulness and effectiveness of the training, any benefits or limitations experienced, and suggestions for improvement. It will be administered as a paper-based tool, with support from a cultural mediator when needed, at the end of the training intervention.
Time frame: End of intervention, at 8 weeks (T1)
To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.
This outcome will be assessed evaluating the change in the levels of Serum total cholesterol (mg/dl), triglycerides (mg/dl), High-Density Lipoproteins (mg/dl) and Low-Density Lipoproteins cholesterol (mg/dl).
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.
This outcome will be assessed evaluating the change in waist circumference (cm)
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.
This outcome will be assessed through evaluating the body weight (kg).
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.
This outcome will be assessed evaluating the change Body Mass Index (BMI) (kg/m\^2).
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
To evaluate the changes, after the intervention, in T2DM severity, through clinical records/physician visits.
This outcome will be assessed evaluating the change in the levels of glycated haemoglobin (HbA1c) - (mmol/mol)
Time frame: Baseline (T0), end of intervention at 8 weeks (T1), 1-month follow-up (T2), and 6-month follow-up (T3)
Started Mar 2025 (actual). Primary completion is estimated for Dec 2026, 21 months after the start.
Of 432 non-industry observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 96. This study's planned 21 months is below that.
Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Marche Region Regional Health Agency