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

August 10, 2019 updated by: Assaf Harofeh MC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

3600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All T1D patients in Israel, born during 1990-2013 and diagnosed prior to January 2015, time of data collection. Inclusion criteria included all patients diagnosed as T1D by a pediatric endocrinologist according to the American Diabetes Association criteria, and treated for their T1D with insulin. Patients are identified from registries of the 13 participating centers.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetes mellitus type 1

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

chart review
Other: chart review
data from charts and from registries will be compared
Non-diabetic
non-diabetic general population born in Israel during 2000-2013, according to the Israeli Health Ministry's Birth Registry (IHMBR) chart review
Other: chart review
data from charts and from registries will be compared

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 years
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
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf Harofeh MC

Collaborators

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

Investigators

  • Principal Investigator: marianna Rachmiel, md, Assaf Haroffeh Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

October 8, 2016

First Submitted That Met QC Criteria

October 8, 2016

First Posted (Estimate)

October 11, 2016

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 10, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 183/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD data will not be available for anyone other than the PI and co-investigators.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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