An observational study in Type 1 Diabetes Mellitus, sponsored by Assaf Harofeh MC. Completed at 1 site in Israel. Open to participants aged 1 Year to 25 Years. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by Assaf Harofeh MC · Observational
The aims of this study are:
A national cohort study, including linkage of data from 13 pediatric diabetes centers and Israeli National Registries, including all patients with T1D born during 1990-2013. Data collected includes: ethnicity, gestational age, birth season, age and season at T1DM diagnosis, and presence of autoimmunity in family. The prevalence of prematurity among T1D is compared to the non-diabetic general population registry of 2000-2013. Additional comparisons are between T1D patients born term and preterm, aimed to unveil specific influencing clinical and epidemiological factors.
In the latter part of the study, a multi-centered, paired case-control study is performed.
Preterm born T1D patients will be paired to matched non-diabetic children at a ratio of 3:1, according to medical center, sex, gestational week of birth, season and year of birth. Data collected includes: ethnicity, family history of autoimmune diseases, age and type of first enteral nutrition, and pharmacological exposures.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's planned enrollment of 3,600 is above the median of 121 across 769 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Assaf Harofeh MC is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All T1D patients in Israel, born during 1990-2013 and diagnosed prior to January 2015, time of data collection. Inclusion criteria included all patients diagnosed as T1D by a pediatric endocrinologist according to the American Diabetes Association criteria, and treated for their T1D with insulin. Patients are identified from registries of the 13 participating centers.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
all T1DM patients in Israel, born during 2000-2013 and diagnosed prior to January 2015. chart review
Other: chart review
non-diabetic general population born in Israel during 2000-2013, according to the Israeli Health Ministry's Birth Registry (IHMBR) chart review
Other: chart review
data from charts and from registries will be compared
prematurity prevalence among T1D patients
the number of premature born among those with type 1 diaetes compared to prematurity in health non diabetic population
Time frame: 1 years
food exposure of premature who developed T1DM compared with prematures who did not develop diabetes
75 files of premies with T1DM will be ccompared to 225 charts of premies, non diabetic for age of food initiation
Time frame: 1 years
Medications exposure in premature who developed T1DM compared with prematures who did not develop diabetes
75 files of premies with T1DM will be ccompared to 225 charts of premies, non diabetic for age and type of drugs initiation
Time frame: 1 years
Plan to share: No — IPD data will not be available for anyone other than the PI and co-investigators.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Assaf Harofeh MC