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Completed

NCT Number: NCT02929953

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chart review

Other

data from charts and from registries will be compared

Primary outcomes

  1. prematurity prevalence among T1D patients

    Time frame: 1 years

    the number of premature born among those with type 1 diaetes compared to prematurity in health non diabetic population

Secondary outcomes

  1. food exposure of premature who developed T1DM compared with prematures who did not develop diabetes

    Time frame: 1 years

    75 files of premies with T1DM will be ccompared to 225 charts of premies, non diabetic for age of food initiation

  2. Medications exposure in premature who developed T1DM compared with prematures who did not develop diabetes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assaf Harofeh MC

Other Gov

Collaborators

  • HaEmek Medical Center, Israel
  • Hadassah Medical Organization
  • Kaplan Medical Center
  • Maccabi Healthcare Services, Israel
  • Rambam Health Care Campus
  • Schneider Children's Medical Center, Israel
  • Shaare Zedek Medical Center
  • Soroka University Medical Center
  • Tel-Aviv Sourasky Medical Center
  • Wolfson Medical Center
  • Ziv Medical Center

Registry information

Official study 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

Acronym: T1Dpremies

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2016
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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