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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788341
• Other study ID #: RMC009523ctil
• Status: Recruiting
• Start date: May 30, 2023
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Rabin Medical Center
• Contact: Alona Hamou, Msc
• Phone: 972-545-950277
• Email: alonah[@]clalit.org.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
Israel	Schneider Children Medical Center of Israel	Petach-Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Provention Bio, Inc.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Islet Autoantibodies		Screening visit