Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04834518
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2021-04-04
Brief Title:
Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADIR
Brief Summary:
A national screening program for children aged 9 months-5 years that will be tested for the presence of islet autoantibodiesUp to 50000 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 1000-10000 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 ageWhen 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 Childrens Medical Center of Israel
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None