NCT05841719: UNISCREEN

Universal Capillary Screening for Chronic Autoimmune, Metabolic and Cardiovascular Diseases: Feasibility and Acceptability Pilot Study.

Completed NA Last updated 6 March 2024

What this trial tests

NA trial testing Screening test in Cardiovascular Risk Factors in 1,535 participants. Completed in 1 January 2024.

Timeline

22 April 2023

Primary endpoint
31 December 2023

1 January 2024

Quick facts

Lead sponsor	Emanuele Bosi
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	1,535
Start date	22 April 2023
Primary completion	31 December 2023
Estimated completion	1 January 2024
Sites	1 location across Italy

Drugs / interventions tested

• Screening test

Conditions studied

• Cardiovascular Risk Factors — all drugs for Cardiovascular Risk Factors →
• Autoimmune Diseases — all drugs for Autoimmune Diseases →

Sponsor

Emanuele Bosi

Who can join

Eligibility, any sex, with Cardiovascular Risk Factors or Autoimmune Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study represents a model for a public health program based on a general population screening for the most prevalent chronic metabolic, cardiovascular and autoimmune diseases across adulthood, childhood and adolescence. The main purpose is to assess feasibility and acceptability of using a capillary screening for this purpose. Secondly, it will be possibile to identify people at increased risk of developing one of these health conditions as well as those who are at pre-symptomatic clinical stages. Risk assessment is needed to identify prevention strategies; early diagnosis allows to start early treatment interventions aimed at reducing lifetime complications.This interventional study will enroll volunteers from Cantalupo, a locality belonging to the Municipality of Cerro Maggiore (Milan). Participants will be offered to undergo two capillary blood sampling to test blood glucose levels, glycated haemoglobin, total cholesterol, HDL-c, LDL-c, triglycerides and specific antibodies for type 1 diabetes and celiac disease. In case a participant screens positive for type I diabetes and/or celiac disease, they will be subsequently invited to undergo a new confirmatory blood draw on venous blood. Blood pressure will be also measured for each participant

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Universal screening for early detection of chronic autoimmune, metabolic and cardiovascular diseases in the general population using capillary blood (UNISCREEN): low-risk interventional, single-centre, pilot study protocol.
   Merolla A, De Lorenzo R, Ferrannini G, Renzi C, et al · · 2024 · cited 6× · PMID 38448070 · DOI 10.1136/bmjopen-2023-078983
2. Universal capillary screening for chronic autoimmune, metabolic and cardiovascular diseases: feasibility and acceptability of the UNISCREEN study.
   Angiulli S, Merolla A, Borgonovo E, De Lorenzo R, et al · · 2025 · cited 5× · PMID 40008147 · DOI 10.3389/fpubh.2025.1506240
3. Feasibility and performance of minimal-volume capillary blood screening for type 1 diabetes and coeliac disease autoantibodies across all age groups: the UNISCREEN population study.
   Marzinotto I, Bazzigaluppi E, Brigatti C, Martinenghi S, et al · · 2026 · PMID 41665666 · DOI 10.1007/s00125-026-06680-y
4. Universal screening for early detection of chronic autoimmune, metabolic and cardiovascular diseases in the general population using capillary blood (UNISCREEN): low-risk interventional, single-centre, pilot study protocol
   Merolla A, De Lorenzo R, Ferrannini G, Renzi C, et al · · 2024