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

Type1diabetes Clinical Trial

— ADIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04834518
• Other study ID #: 018620RMC & 18420COM
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: March 31, 2027

Study information

• Verified date: March 2024
• Source: Rabin Medical Center
• Contact: Moshe Phillip, Prof
• Phone: 972-544-795-995
• Email: moshe.phillip[@]phillipmd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Gender: All
• Age group: 9 Months to 5 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Beer-Sheva
Israel	Rambam Medical Center	Haifa
Israel	Hadassah medical Center	Jerusalem
Israel	Schneider Children Medical Center of Israel	Petach-Tikva
Israel	Child Health Centers all over Israel (clalit Health Services)	Petah-Tikva
Israel	Sheba Medical Center	Ramat-Gan
Israel	Dana-Duek children's hospital	Tel-Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of presymptomatic type 1 diabetes	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
Primary	Frequency of Diabetic Ketoacidosis on the clinical presentation of Type 1 Diabetes		End of screening and follow-up period-4 years after obtaining the first screening test
Secondary	The average age of islet autoantibody seroconversion		End of screening and follow-up period-4 years after obtaining the first screening test
Secondary	The rate of islet autoantibody seroconversion		End of screening and follow-up period-4 years after obtaining the first screening test
Secondary	The rate of progression from pre-symptomatic T1D to clinical diabetes		End of screening and follow-up period-4 years after obtaining the first screening test