Related Experiment Video
Updated: Jul 1, 2025
A High-Throughput Multiplexed Screening for Type 1 Diabetes, Celiac Diseases, and COVID-19
Published on: July 5, 2022
Universal screening for early detection of chronic autoimmune, metabolic and cardiovascular diseases in the general
Aurora Merolla1, Rebecca De Lorenzo1, Giulia Ferrannini2
1Vita-Salute San Raffaele University, Milano, Italy.
Insights
Universal screening using capillary blood tests is feasible for early detection of type 1 diabetes and coeliac disease. This pilot study assesses the acceptability and effectiveness of this public health approach.
Area of Science:
- Public Health
- Preventive Medicine
- Clinical Diagnostics
Background:
- Chronic autoimmune and metabolic diseases pose a significant public health burden.
- Early detection through universal screening can mitigate disease impact.
- Current screening methods may not be universally accessible.
Purpose of the Study:
- To assess the feasibility and acceptability of universal screening using capillary blood sampling.
- To determine the prevalence of presymptomatic type 1 diabetes and undiagnosed coeliac disease.
- To evaluate the distribution of glucose, glycated haemoglobin, and lipid profiles in a general population.
Main Methods:
- A pilot, interventional study (UNISCREEN) involving volunteers aged 1-100.
- Capillary blood collection for autoantibodies, glucose, HbA1c, and lipids using point-of-care devices.
- Inclusion of interviews, blood pressure measurement, and feasibility questionnaires.
Main Results:
- The study aims to assess feasibility and acceptability of capillary blood screening.
- Prevalence of presymptomatic type 1 diabetes and undiagnosed coeliac disease will be determined.
- Cardiovascular risk factors and metabolic parameters will be analyzed.
Conclusions:
- Feasible and acceptable universal screening models can support large-scale public health initiatives.
- This approach offers opportunities for innovative public health programs.
- Early detection of chronic diseases can lead to better health outcomes.
Introduction:
Chronic autoimmune (type 1 diabetes and coeliac disease) and metabolic/cardiovascular (type 2 diabetes, dyslipidaemia, hypertension) diseases are highly prevalent across all age ranges representing a major public health burden. Universal screening for prediction/early identification of these conditions is a potential tool for reducing their impact on the general population. The aim of this study is to assess whether universal screening using capillary blood sampling is feasible at a population-based level.
Methods And Analysis:
This is a low-risk interventional, single-centre, pilot study for a population-based screening programme denominated UNISCREEN. Participants are volunteers aged 1-100 who reside in the town of Cantalupo (Milan, Italy) undergoing: (1) interview collecting demographics, anthropometrics and medical history; (2) capillary blood collection for measurement of type 1 diabetes and coeliac disease-specific autoantibodies and immediate measurement of glucose, glycated haemoglobin and lipid panel by point-of-care devices; (3) venous blood sampling to confirm autoantibody-positivity; (4) blood pressure measurement; (5) fulfilment of a feasibility and acceptability questionnaire. The outcomes are the assessment of feasibility and acceptability of capillary blood screening, the prevalence of presymptomatic type 1 diabetes and undiagnosed coeliac disease, distribution of glucose categories, lipid panel and estimate of cardiovascular risk in the study population. With approximately 3000 inhabitants, the screened population is expected to encompass at least half of its size, approaching nearly 1500 individuals.
Ethics And Dissemination:
This protocol and the informed consent forms have been reviewed and approved by the San Raffaele Hospital Ethics Committee (approval number: 131/INT/2022). Written informed consent is obtained from all study participants or their parents if aged <18. Results will be published in scientific journals and presented at meetings.
Conclusions:
If proven feasible and acceptable, this universal screening model would pave the way for larger-scale programmes, providing an opportunity for the implementation of innovative public health programmes in the general population.
Trial Registration Number:
NCT05841719.
