Background and Aims: A pre-clinical stage of type 1 diabetes (T1D) often precedes by many years the overt clinical symptoms. Diagnosis during this period is often difficult and is based on the presence of specific islet autoantibodies in the subject's blood. First-degree relatives of patients with T1D were tested using the 3 Screen ICA TM ELISA (RSR Ltd) for combined testing for autoantibodies to GAD65 (glutamic acid decarboxylase, 65kDa isoform), ZnT8 (zinc transporter 8), and the islet antigen IA-2. 3 Screen positives were subsequently tested for individual antibodies. Potentially, approximately 70% of individuals with two or more types of autoantibodies (including IAA, anti-insulin) will need insulin treatment over the next 10 years.
Methods: Clinical Centers from Białystok (n=237), Rzeszów (n=80), Poznań (n=74), Warsaw IP-CZD (n=109), Warsaw (n=42), Opole (n=85), Wrocław (n=90), Gdańsk (n=55), Łódź (n=118), Katowice (n=46), Kraków (n=14), Szczecin (n=20), Bydgoszcz (n=44), Lublin (n=42) participated in the study, a total of 1056 patients (age 1-18). Blood was sent to the coordinating clinic and forwarded to FIRS Laboratories, RSR Ltd (Cardiff, UK) for testing. 3 Screen positive serum samples were assayed in the GAD65 Ab ELISA, IA-2 Ab ELISA, ZnT8 Ab ELISA and the Insulin Ab RIA (www.rsrltd.com).
Results: Out of 1056 samples n=85 (8,04%) were 3 Screen positive, 59 children with multiple autoantibodies were identified as pre-clinical diabetes (5,58%). As follow-up oral glucose tolerance test and glycated hemoglobin were performed.
Conclusions: Early detection of islet autoantibodies by 3 Screen identifies pre-clinical T1D preceding carbohydrate abnormalities and give the possibility of therapeutic interventions in innovative clinical programs. Patients covered by early education and multidirectional diabetes care will avoid the severe clinical condition associated with ketoacidosis.
15 Sep 2022 - 17 Sep 2022