This trial is active, not recruiting.

Condition type 1 diabetes mellitus
Treatment chart review
Sponsor Assaf Harofeh MC
Collaborator Shaare Zedek Medical Center
Start date January 2014
End date December 2017
Trial size 3600 participants
Trial identifier NCT02929953, 183/13


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
all T1DM patients in Israel, born during 2000-2013 and diagnosed prior to January 2015. chart review
chart review
data from charts and from registries will be compared
non-diabetic general population born in Israel during 2000-2013, according to the Israeli Health Ministry's Birth Registry (IHMBR) chart review
chart review
data from charts and from registries will be compared

Primary Outcomes

prematurity prevalence among T1D patients
time frame: 1 years

Secondary Outcomes

food exposure of premature who developed T1DM compared with prematures who did not develop diabetes
time frame: 1 years
Medications exposure in premature who developed T1DM compared with prematures who did not develop diabetes
time frame: 1 years

Eligibility Criteria

Male or female participants from 1 year up to 25 years old.

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

Additional Information

Official title 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
Principal investigator marianna Rachmiel, md
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Assaf-Harofeh Medical Center.