Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus

Обзор

A national screening program for children aged 9 months-5 years that will be tested for the presence of islet autoantibodies.Up to 50,000 Children will be screened by their primary care physician all over Israel. The initial screening will be done at the age of 1 year (in conjunction with the routinely collection of blood for CBC ) and repeated at ages 2-5 years. Antibodies will be measured in capillary blood samples using the Ultrasensitive Antibody Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods. By using this innovative technology in such a large cohort, the study is anticipated to detect antibodies at an unprecedented earlier age.When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology. In addition, multiple antibodies will be also measured using a radio-binding assay (RBA) of a venous blood sample for investigational purpose only. Children with confirmed multiple antibodies (stage 1 or 2 T1D) will be followed up routinely for the appearance of clinical signs of diabetes (HbA1c, repeated OGTT, monitoring of urine and blood glucose where indicated) and will be invited along with their families to attend an educational program. This program will include diabetes education emphasizing on DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. The analysis and storage of the samples will be done in a single screening center at Schneider Children's Medical Center of Israel.

Первичные конечные точки

• Diagnosis of presymptomatic type 1 diabetes [Срок оценки: End of screening and follow-up period-4 years after obtaining the first screening test]
• Frequency of Diabetic Ketoacidosis on the clinical presentation of Type 1 Diabetes [Срок оценки: End of screening and follow-up period-4 years after obtaining the first screening test]

Вторичные конечные точки (3)

• The average age of islet autoantibody seroconversion [Срок оценки: End of screening and follow-up period-4 years after obtaining the first screening test]
• The rate of islet autoantibody seroconversion [Срок оценки: End of screening and follow-up period-4 years after obtaining the first screening test]
• The rate of progression from pre-symptomatic T1D to clinical diabetes [Срок оценки: End of screening and follow-up period-4 years after obtaining the first screening test]

Критерии участия

Критерии включения

• Informed consent obtained before any trial-related activities
• Children aged 9-months- 5 years at first screening.

Критерии исключения

• Known diagnosis of diabetes (Type 1 or other)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Израиль · 7 центров

• Soroka Medical Center — Beersheba
• Rambam Medical Center — Haifa
• Hadassah medical Center — Jerusalem
• Child Health Centers all over Israel (clalit Health Services) — Petah Tikva
• Schneider Children Medical Center of Israel — Petah Tikva
• Sheba Medical Center — Ramat Gan
• Dana-Duek children's hospital — Tel Aviv

Идентификаторы

NCT: NCT04834518 · 018620RMC & 18420COM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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