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A national Screening program for the presence of Islet Autoantibodies (IA) in relatives of people with type 1 diabetes (PWT1D) aiming at identifying people with pre-clinical (stage 1 & 2) T1D and DKA prevention on the clinical presentation of T1D. All participants will be screened at study entry for the presence of 4 islet autoantibodies: glutamic acid decarboxylase antibody (GADA), insulinoma-associated-2 antibody (IA-2A), insulin antibodies (IAA) and Zinc transporter-8 antibodies (ZnT8A). The ADAP assay will be used to detect IA.
A confirmation blood sample for positive participants with two or more IA will be taken. The confirmation analysis will be done by the ADAP assay, conventional ELISA, and RIA.
Participants identified as part of the study with pre-symptomatic type 1 diabetes (T1D) (stages 1 and 2) will be referred to complete an educational program emphasizing DKA prevention as part of routine medical care .During the study, cases of stage 2 and stage 3 diabetes and DKA events in participants who are positive for IA will be documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative result at the autoantibodies screening test |
| ||
| Positive result at the autoantibodies screening test | Participants with two or more positive autoantibodies:
|
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| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of multiple antibodies among first-degree relatives of Type I Diabetes probands in Israel | End of screening, 3 years after obtaining the first screening test |
| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of Diabetic Ketoacidosis at Type 1 Diabetes presentation among the screened cohort | End of screening, 3 years after obtaining the first screening test | |
| Proportion and rate of progression from stage 1 to stage 2 and stage 3 Type 1 Diabetes |
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Inclusion Criteria:
Exclusion Criteria:
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First degree relatives of patients with Type 1 diabetes from all over Israel, aged 2-45 years old
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moshe Phillip, Prof. | Contact | 972-544-795995 | moshe.phillip@phillipmd.com | |
| Alona Hamou, Msc | Contact | 972-545-950277 | alonah@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, Prof. | Schneider Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children Medical Center of Israel | Recruiting | Petah Tikva | Israel |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| End of screening, 3 years after obtaining the first screening test |
| >500 individuals with pre-clinical Type 1 Diabetes identified in the cohort | End of screening, 3 years after obtaining the first screening test |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |