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

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Other: chart review

• Registration Number: NCT02929953
• Lead Sponsor: Assaf Harofeh MC

Brief 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2016-10-08
• Study First Submitted QC: 2016-10-08
• Study First Posted: 2016-10-11
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-10
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3600

Inclusion Criteria

1. Patients diagnosed with T1D
2. Patients treated in one of the 13 participating centers
3. 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
4. Patients for whom a complete medical record is available

Exclusion Criteria

1. Lack of birth data
2. Unknown type of diabetes
3. For case control portion, an incomplete medical record/inadequate documentation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-diabetic	chart review	non-diabetic general population born in Israel during 2000-2013, according to the Israeli Health Ministry's Birth Registry (IHMBR) chart review
Diabetes mellitus type 1	chart review	all T1DM patients in Israel, born during 2000-2013 and diagnosed prior to January 2015. chart review

Primary Outcome Measures

Name	Time	Method
prematurity prevalence among T1D patients	1 years	the number of premature born among those with type 1 diaetes compared to prematurity in health non diabetic population

Secondary Outcome Measures

Name	Time	Method
food exposure of premature who developed T1DM compared with prematures who did not develop diabetes	1 years	75 files of premies with T1DM will be ccompared to 225 charts of premies, non diabetic for age of food initiation
Medications exposure in premature who developed T1DM compared with prematures who did not develop diabetes	1 years	75 files of premies with T1DM will be ccompared to 225 charts of premies, non diabetic for age and type of drugs initiation

Trial Locations

Locations (1)

Assaf Harofeh Medical Center; 🇮🇱 Zerifin, Israel