The Israeli Study for Islet Autoantibodies Screening in Families of Type-1 Diabetes Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-30

Study Completion Date

2025-04-30

Brief Summary

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We aim at establishing a research program that will offer screening for the presence of Islet Autoantibodies (IA) in relatives of people with Type 1 Diabetes (T1D).

Relatives of people with diabetes, children, and adults from our clinic and all over Israel will be offered to participate in the study. The presence of IA will be evaluated using the Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods.. When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology and by a radio binding assay (RBA). People positive for one or more antibodies (stage 1 or 2 T1D) will be referred to attend an educational program at our center. This program will include diabetes education emphasizing DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. After the educational visit, people at risk of developing diabetes will be referred to further follow-up and evaluation under routine medical care at our center.

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Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* First degree family member (sibling or parent) of a known T1D patient
* Age 2-45 years
* Signing an informed consent

Exclusion Criteria

* Known diabetes of any kind (type 2, MODY)
* Have a previous history of being treated with insulin or oral diabetes medications.
* Currently be using systemic immunosuppressive agents (topical and inhaled agents are acceptable)

Minimum Eligible Age

2 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes