NCT02929953

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,600 (estimated)
• Sponsor: Assaf Harofeh MC · Other Government
• Sex: All
• Age: 1 Year – 25 Years
• Healthy volunteers: Not accepted

Summary

The aims of this study are: 1. 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. 2. 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

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	chart review	data from charts and from registries will be compared

Timeline

• Start date: 2014-01-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2016-10-11
• Last updated: 2019-08-13

Locations

1 site across 1 country: Israel