Clinical trial NCT02929953: Prematurity Prevalence Among T1D Patients and Its Characteristics Compared With Premature-born Non-diabetic Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: premature birth
risk factor
type 1 diabetes mellitus
seasonality
prevalence
enteral feeding
immunomodulating medications
early onset
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Shaare Zedek Medical Center
name: Wolfson Medical Center
name: Ziv Medical Center
name: Schneider Children's Medical Center, Israel
name: Tel-Aviv Sourasky Medical Center
name: Maccabi Healthcare Services, Israel
name: Kaplan Medical Center
name: HaEmek Medical Center, Israel
name: Soroka University Medical Center
name: Rambam Health Care Campus
name: Hadassah Medical Organization
First posted: 2016-10-11
Enrollment: 3600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: prematurity prevalence among T1D patients
timeFrame: 1 years
Secondary outcomes:
measure: food exposure of premature who developed T1DM compared with prematures who did not develop diabetes
timeFrame: 1 years
measure: Medications exposure in premature who developed T1DM compared with prematures who did not develop diabetes
timeFrame: 1 years
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Assaf Haroffeh Medical Center
name: marianna Rachmiel, md
role: PRINCIPAL_INVESTIGATOR
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