Type1diabetesADIRNCT04834518
Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus
An observational study of Type1diabetes, run by Rabin Medical Center at 7 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 9 months to 5 years
- Conditions the study is for
- Type1diabetes
- How many people
- 50,000 participants
- Where
- 7 sitesIsrael
- Study dates
- 1 Apr 2021to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 5 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Informed consent obtained before any trial-related activities
- Children aged 9-months- 5 years at first screening.
Who cannot join
- Known diagnosis of diabetes (Type 1 or other)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Israel7 sites, 7 recruiting
- Recruiting
Soroka Medical Center
Beersheba
Eli Hershkovitz, Prof, EliH@clalit.org.il
Eli Hershkovitz, Prof
- Not yet recruiting
Rambam Medical Center
Haifa
Naim Shehadeh, Prof, n_shehadeh@rambam.health.gov.il
Naim Shehadeh, Prof
- Not yet recruiting
Hadassah medical Center
Jerusalem
David Zangen, Dr, ZANGEND@hadassah.org.il
David Zangen, Dr
- Recruiting
Child Health Centers all over Israel (clalit Health Services)
Petah Tikva
Avner Cohen, Prof, 972-523-870-827, hermanc@tauex.tau.ac.il
Avner Cohen, Prof
- Recruiting
Schneider Children Medical Center of Israel
Petah Tikva
Alona Hamou, MSc, 972-545-950-277, alonah@clalit.org.il
Moshe Phillip, Prof
- Not yet recruiting
Sheba Medical Center
Ramat Gan
Orit Hamiel, Prof, Orit.Hamiel@sheba.health.gov.il
Orit Hamiel, Prof
- Not yet recruiting
Dana-Duek children's hospital
Tel Aviv
Yael Lebenthal, Prof, yaelleb@tlvmc.gov.il
Yael Lebenthal, Prof
About this study
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.
- Conditions
- Type1diabetes
- Keywords
- autoantibodies screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: End of screening and follow-up period-4 years after obtaining the first screening test
Secondary outcomes (3)
The average age of islet autoantibody seroconversion
Measured: End of screening and follow-up period-4 years after obtaining the first screening test
The rate of islet autoantibody seroconversion
Measured: 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
Measured: End of screening and follow-up period-4 years after obtaining the first screening test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Apr 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Prof, Study director, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834518
- Sponsor's protocol ID
- 018620RMC & 18420COM
- Acronym
- ADIR
- Status last verified
- Oct 2024
- First submitted
- 4 Apr 2021
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04834518
- Acronym / sponsor ID
- ADIR / 018620RMC & 18420COM
- Conditions
- Type1diabetes
- Keywords
- autoantibodies screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 9 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Informed consent obtained before any trial-related activities
- Children aged 9-months- 5 years at first screening.
Key exclusion criteria (1 listed)
- Known diagnosis of diabetes (Type 1 or other)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
3 secondary outcomes
The average age of islet autoantibody seroconversion
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moshe Phillip, Prof study director
Schneider Children's Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes, run by Rabin Medical Center at 7 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moshe Phillip, Prof (972-544-795-995, moshe.phillip@phillipmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of presymptomatic type 1 diabetes (time frame: End of screening and follow-up period-4 years after obtaining the first screening test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.