Prematurity Prevalence Among T1D Patients and Its Characteristics Compared With Premature-born Non-diabetic Patients

Study Overview
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Brief Summary
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The aims of this study are: To assess the prevalence of prematurity, especially early prematurity, among T1D patients, and compare it to the prematurity prevalence among the non-diabetic general population in Israel. To characterize epidemiological and clinical factors that differ between premature-born patients that developed T1D and those that have not, including the nutritional and therapeutic properties in NICU.

Detailed Description
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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.

Official Title
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Prevalence of Premature Birth History Among Type 1 Diabetes Mellitus (T1D) Patients and Characteristics of Premature Born Children Who Develop T1D Compared With Those Who do Not

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Other: chart review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with T1D Patients treated in one of the 13 participating centers For the case-control portion of the study, all children born between 1.1.1990-31.12.2013 and admitted to NICU medical centers that have been included in the original cohort portion Patients for whom a complete medical record is available Exclusion Criteria: Lack of birth data Unknown type of diabetes For case control portion, an incomplete medical record/inadequate documentation

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetes mellitus type 1<br>all T1DM patients in Israel, born during 2000-2013 and diagnosed prior to January 2015. chart review | Other: chart review<br>* data from charts and from registries will be compared<br>|
| Non-diabetic<br>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<br>* data from charts and from registries will be compared<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prematurity prevalence among T1D patients | the number of premature born among those with type 1 diaetes compared to prematurity in health non diabetic population | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature birth, risk factor, type 1 diabetes mellitus, seasonality, prevalence, enteral feeding, immunomodulating medications, early onset