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

March 25, 2024 updated by: Rabin Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Beer-Sheva, Israel
        • Recruiting
        • Soroka Medical Center
        • Contact:
        • Principal Investigator:
          • Eli Hershkovitz, Prof
      • Haifa, Israel
      • Jerusalem, Israel
        • Not yet recruiting
        • Hadassah Medical Center
        • Contact:
        • Principal Investigator:
          • David Zangen, Dr
      • Petach-Tikva, Israel
        • Recruiting
        • Schneider Children Medical Center of Israel
        • Principal Investigator:
          • Moshe Phillip, Prof
        • Sub-Investigator:
          • Tal Oron, Dr.
        • Contact:
      • Petah-Tikva, Israel
        • Recruiting
        • Child Health Centers all over Israel (clalit Health Services)
        • Contact:
        • Principal Investigator:
          • Avner Cohen, Prof
      • Ramat-Gan, Israel
      • Tel-Aviv, Israel
        • Not yet recruiting
        • Dana-Duek children's hospital
        • Contact:
        • Principal Investigator:
          • Yael Lebenthal, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 1 year (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Children from the general population of all over Israel, aged 9 months-5 years arriving to the routine blood test for CBC or to any other routine visit to the community pediatrician.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of presymptomatic type 1 diabetes
Time Frame: End of screening and follow-up period-4 years after obtaining the first screening test

Presymptomatic type 1 diabetes, defined as positive for 2 or more islet autoantibodies (GADA, IA-2A, and IAA) or those with high levels of a single antibody in both the screening and confirmation samples or in the screening sample plus a diagnosis of diabetes prior to obtaining the conformation sample.

Presymptomatic type 1 diabetes will be classified as stage 1, 2, or 3:

  • Stage 1 will be defined as 2 or more islet autoantibodies or high levels of a single antibody and normal glucose tolerance based on OGTT results. (not including patients with only a single antibody who have first degree relative with type 1 diabetes)
  • Stage 2 will be defined as 1 or more islet autoantibodies accompanied by dysglycemia (fasting plasma glucose of 110-125 mg/dL or impaired 2-hour plasma glucose of 140- 199 mg/dL and/or plasma glucose ≥200 mg/dL at intermediate time points [30, 60, 90 minutes]) based on OGTT results.
  • Stage 3 will be defined according to the American Diabetes Association criteria
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
Time Frame: End of screening and follow-up period-4 years after obtaining the first screening test
End of screening and follow-up period-4 years after obtaining the first screening test

Secondary Outcome Measures

Outcome Measure
Time Frame
The average age of islet autoantibody seroconversion
Time Frame: End of screening and follow-up period-4 years after obtaining the first screening test
End of screening and follow-up period-4 years after obtaining the first screening test
The rate of islet autoantibody seroconversion
Time Frame: End of screening and follow-up period-4 years after obtaining the first screening test
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
Time Frame: End of screening and follow-up period-4 years after obtaining the first screening test
End of screening and follow-up period-4 years after obtaining the first screening test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Collaborators

Juvenile Diabetes Research Foundation

Investigators

  • Study Director: Moshe Phillip, Prof, Schneider Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

April 4, 2021

First Submitted That Met QC Criteria

April 4, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 018620RMC & 18420COM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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