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

NCT ID: NCT04834518

Last Updated: 2024-10-17

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

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type1diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Negative result at the first autoantibodies screening test

Participants will be invited to repeat the screening test at the age of 2-5 years old

No interventions assigned to this group

Positive result at the first or second autoantibodies screening test

* Participants will be monitored annually for risk of type 1 diabetes. (HbA1c, repeated OGTT, monitoring of urine and blood glucose where indicated)
* Families will attend diabetes-educational program emphasizing on DKA prevention
* Stress assessment for the families involved and stress alleviating interventions when required.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Known diagnosis of diabetes (Type 1 or other)
Minimum Eligible Age

9 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juvenile Diabetes Research Foundation

OTHER

Sponsor Role collaborator

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moshe Phillip, Prof

Role: STUDY_DIRECTOR

Schneider Children's Medical Center

Locations

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Soroka Medical Center

Beersheba, , Israel

Site Status RECRUITING

Rambam Medical Center

Haifa, , Israel

Site Status NOT_YET_RECRUITING

Hadassah medical Center

Jerusalem, , Israel

Site Status NOT_YET_RECRUITING

Child Health Centers all over Israel (clalit Health Services)

Petah Tikva, , Israel

Site Status RECRUITING

Schneider Children Medical Center of Israel

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center

Ramat Gan, , Israel

Site Status NOT_YET_RECRUITING

Dana-Duek children's hospital

Tel Aviv, , Israel

Site Status NOT_YET_RECRUITING

Countries

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Israel

Central Contacts

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Moshe Phillip, Prof

Role: CONTACT

972-544-795-995

Alona Hamou, MSc

Role: CONTACT

972-545-950-277

Facility Contacts

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Eli Hershkovitz, Prof

Role: primary

Eli Hershkovitz, Prof

Role: backup

Naim Shehadeh, Prof

Role: primary

Naim Shehadeh, Prof

Role: backup

David Zangen, Dr

Role: primary

David Zangen, Dr

Role: backup

Avner Cohen, Prof

Role: primary

972-523-870-827

Avner Cohen, Prof

Role: backup

Alona Hamou, MSc

Role: primary

972-545-950-277

Moshe Phillip, Prof

Role: backup

Tal Oron, Dr.

Role: backup

Orit Hamiel, Prof

Role: primary

Orit Hamiel, Prof

Role: backup

Yael Lebenthal, Prof

Role: primary

Yael Lebenthal, Prof

Role: backup

Other Identifiers

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018620RMC & 18420COM

Identifier Type: -

Identifier Source: org_study_id

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