Prematurity Prevalence Among T1D Patients and Its Characteristics Compared With Premature-born Non-diabetic Patients (T1Dpremies)

Assaf Harofeh MC

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Other: chart review

Study type: Observational

Funder types: Other

Identifiers

NCT02929953

183/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,600 estimated patients

Sex: All

Ages: 1 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

3,600 participants in 2 patient groups

Diabetes mellitus type 1

Description:

all T1DM patients in Israel, born during 2000-2013 and diagnosed prior to January 2015. chart review

Treatment:

Other: chart review

Non-diabetic

Description:

non-diabetic general population born in Israel during 2000-2013, according to the Israeli Health Ministry's Birth Registry (IHMBR) chart review

Treatment:

Other: chart review