About this trial
This study aims to test the feasibility of a new systematic screening program to allow the early detection of individuals aged 50 years at risk of type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVDs) in the resident in the province of Ascoli Piceno and without previous diagnosis, using the CUORE and FINDRISDC tools developed in the Project.
The intervention will be conducted at the premises of the Prevention Department in Ascoli Piceno and San Benedetto del Tronto, within the Local Health Authority of Ascoli Piceno (Marche Region, Italy), throughout 2026.
Eligible individuals will be invited, based on recruitment criteria, to the screening via a letter containing study information and participation instructions. Those willing to participate will book the appointment to undergo the screening in one of the two premises of the Prevention Department involved in the study (namely, San Benedetto del Tronto and Ascoli Piceno), through the regional reservation system (CUP). On the scheduled date, participants will visit the Prevention Department, where healthcare professionals (HCPs) will explain the study, obtain the informed consent, and collect data related to the CUORE and/or FINDRISC questionnaires, as well as sociodemographic information. The calculated scores will determine the 10-year risks of T2DM and major CVD events. Based on these risks, participants will be provided with tailored suggested pathways. A summary letter outlining these pathways will be delivered, and, in case of consent, results will be added to the participants' Electronic Health Record. Follow-up calls will be scheduled at 3 (T1) and 6 (T2) months to assess adherence to the suggested pathway (e.g., visit the General Practitioner (GP), lifestyle counselling) through a phone call.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Citizens resident in Ascoli Piceno province
People turning 50 in 2026
Capacity to consent
Fulfilling and signing the informed consent related to the participation to the study.
Disqualifiers
a concomitant diagnosis of DM and a previous CVD major event (one or more between Myocardial infarction, Haemorrhagic and/or ischaemic stroke, Revascularization interventions, as percutaneous coronary intervention/coronary artery bypass graft)
Failure to meet the inclusion criteria
Lack of written informed consent.
Trial population
The target population will be composed by the residents of Ascoli Piceno province (one of the inclusion criteria)
Trial design
Cohort
Prospective
Treatments tested in this trial
Screening program
Other interventionThe intervention will consist in a systematic screening of the participants to identify people at risk of developing T2DM (FINDRISC questionnaire) and CVDs (CUORE questionnaire, along with HbA1c).
Treatment groups
Trial outcomes
Primary outcomes
To assess the screening adherence through coverage
This outcome will be assessed computing the percentage (%) of screening participants against invited
Secondary outcomes
To evaluate the 10-years risk of developing Type 2 Diabetes event for each person
This outcome will be assessed evaluating the scores derived from FINDRISC tool, along with Glycated Hemoglobin (HbA1c), to determine risk of developing diabetes. FINDRISC uses: * age (score=2 for people aged 50 years) * vegetable \& fruit intake (every day=0; otherwise= 1) * history of hyperglycemia (no=0; yes=5; ) * Body Mass Index (BMI) (kg/m\^2) (from 0 to 3, as increases) * physical activity (yes=0; no=2) * medical treatment of hypertension (yes=2; no=1) * family history of diabetes (no=0; otherwise, up to 5) * waist circumference (cm) (from 0 to 4, as increases) The detection of the HbA1c will be conducted for the moderate, high and very high-risk levels, to accurately complete the risk assessment for results \>9, a cut-off level suggestive of further investigation, as per literature. Based on the final score, ranging from 0 to 26, four risk levels are defined: I- Low risk (≤9); II- Moderate risk (\>9≤15 score); III: High risk (\>15 ≤20 score); IV- Very high risk (\> 20 score).
To evaluate the 10-years risk of developing a major Cardiovascular risk event for each person
This outcome will be assessed evaluating the scores derived from CUORE tool, representing the probability of experiencing a first major cardiovascular event (myocardial infarction or stroke) in the next 10 years, based on 8 risk factors: gender, age, diabetes, smoking habit, systolic blood pressure (mmHg), total cholesterolaemia (mg/dl), High-Density Lipoprotein-cholesterolaemia (mg/dl) and anti-hypertensive treatment. The individual score is computed by the formula: 1 - \[S(t)\] \^ {EXP \[β1 × age + β2 × PAS + β3 × COL + β4 × HDL + β5 (if SMOKER) + β6 (if DIABETIC) + β7 (if TREATED with antihypertensives) - G(µ)\]}; S(t)=10-year survival evaluated at the mean value of the factors; βi= the coefficients of the risk factors; G(µ)= linear combination of the factor averages or prevalence in each cathegory by the respective coefficients βi. Based on the final score (from 0% to 100%), 3 risk levels are identified: I- Low risk: \<3%; II- Moderate risk: ≥3-\<20%; III: High risk: ≥20%.
To determine the Diabetes Mellitus Type 2 risk detection rate
This outcome will be assessed evaluating the proportion of persons with unrecognized risk of developing Diabetes Mellitus Type 2, by using the final scores from the FINDRISC tool, along with Glycated Hemoglobin, when foreseen. This detection rate is calculated as the proportion of individuals identified as having moderate, high, or very high risk of developing diabetes over the next decade, based on the FINDRISC scores.
To determine the Cardiovascular Diseases' risk detection rate
This outcome will be assessed evaluating the proportion of persons with unrecognized risk of developing a major Cardiovascula Diseases, by using the final scores from the CUORE tool, which predicts the probability of experiencing a first major cardiovascular event (such as myocardial infarction or stroke) within the next 10 years This detection rate is calculated as the proportion of individuals identified as having moderate, high, or very high risk of developing cardiovascular disease over the next decade, based on the CUORE score.
Sponsors and contacts
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Marche Region Regional Health Agency
Lead sponsor
REGIONAL HEALTH UNIT - MARCHE REGION - AREA 5 (ASUR Marche, Area Vasta 5, Distretto Sanitario San Benedetto), Italy
Collaborator
Azienda Sanitaria Locale USL 13 Ospedale Mazzoni di Ascoli Piceno
Collaborator