Type 1 Diabetes MellitusT1DpremiesNCT02929953

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

An observational study of Type 1 Diabetes Mellitus, run by Assaf Harofeh MC at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 1 year to 25 years
Conditions the study is for: Type 1 Diabetes Mellitus
What is being tested?: chart review
How many people: 3,600 participants
Where: 1 siteIsrael
Study dates: Jan 2014to Apr 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 25 years
All sexes
No healthy volunteers
Child, Adult

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.

Who may be able to join

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

Who cannot join

Lack of birth data
Unknown type of diabetes
For case control portion, an incomplete medical record/inadequate documentation

Trial locations and contacts

1 site in 1 country.

Israel1 site

Assaf Harofeh Medical Center
Tsrifin, 70300

Other trials in Israel

About this study

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

The aims of this study are:

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.
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.

Read the 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.

Conditions: Type 1 Diabetes Mellitus
Being tested: chart review
Keywords: premature birth, risk factor, type 1 diabetes mellitus, seasonality, prevalence, enteral feeding, immunomodulating medications, early onset
Medical subject headings: Diabetes Mellitus, Type 1, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

chart reviewOther
data from charts and from registries will be compared

Study groups in NCT02929953
Study group	Role	What they receive
Diabetes mellitus type 1		all T1DM patients in Israel, born during 2000-2013 and diagnosed prior to January 2015. chart review Receives: Other: chart review
Non-diabetic		non-diabetic general population born in Israel during 2000-2013, according to the Israeli Health Ministry's Birth Registry (IHMBR) chart review Receives: Other: chart review

What is being measured

The primary outcome is the main question the study is designed to answer.

prematurity prevalence among T1D patients
the number of premature born among those with type 1 diaetes compared to prematurity in health non diabetic population
Measured: 1 years

Secondary outcomes (2)

food exposure of premature who developed T1DM compared with prematures who did not develop diabetes
75 files of premies with T1DM will be ccompared to 225 charts of premies, non diabetic for age of food initiation
Measured: 1 years
Medications exposure in premature who developed T1DM compared with prematures who did not develop diabetes
75 files of premies with T1DM will be ccompared to 225 charts of premies, non diabetic for age and type of drugs initiation
Measured: 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Apr 2019

First posted11 Oct 2016 (estimated)
Study startJan 2014
Primary completionApr 2019
Study completionApr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 3,600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02929953
Sponsor's protocol ID: 183/13
Acronym: T1Dpremies
Status last verified: Aug 2019
First submitted: 8 Oct 2016
Last updated: 13 Aug 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No: IPD data will not be available for anyone other than the PI and co-investigators.

Publications

Blumenfeld O, Dichtiar R, Shohat T; Israel IDDM Registry Study Group (IIRSG). Trends in the incidence of type 1 diabetes among Jews and Arabs in Israel. Pediatr Diabetes. 2014 Sep;15(6):422-7. doi: 10.1111/pedi.12101. Epub 2013 Nov 27.
PubMed 24283719
Egro FM. Why is type 1 diabetes increasing? J Mol Endocrinol. 2013 Jul 12;51(1):R1-13. doi: 10.1530/JME-13-0067. Print 2013.
PubMed 23733895
De Curtis M, Rigo J. The nutrition of preterm infants. Early Hum Dev. 2012 Mar;88 Suppl 1:S5-7. doi: 10.1016/j.earlhumdev.2011.12.020. Epub 2012 Jan 17.
PubMed 22261289
Working Group Of Pediatrics Chinese Society Of Parenteral And Enteral Nutrition, Working Group Of Neonatology Chinese Society Of Pediatrics, Working Group Of Neonatal Surgery Chinese Society Of Pediatric Surgery. CSPEN guidelines for nutrition support in neonates. Asia Pac J Clin Nutr. 2013;22(4):655-63. doi: 10.6133/apjcn.2013.22.4.21.
PubMed 24231027
Kagohashi Y, Otani H. Role of nutritional factors at the early life stages in the pathogenesis and clinical course of type 1 diabetes. Biomed Res Int. 2015;2015:382165. doi: 10.1155/2015/382165. Epub 2015 Mar 26.
PubMed 25883958
Ziegler AG, Pflueger M, Winkler C, Achenbach P, Akolkar B, Krischer JP, Bonifacio E. Accelerated progression from islet autoimmunity to diabetes is causing the escalating incidence of type 1 diabetes in young children. J Autoimmun. 2011 Aug;37(1):3-7. doi: 10.1016/j.jaut.2011.02.004. Epub 2011 Mar 3.
PubMed 21376535
Jaberi-Douraki M, Liu SW, Pietropaolo M, Khadra A. Autoimmune responses in T1DM: quantitative methods to understand onset, progression, and prevention of disease. Pediatr Diabetes. 2014 May;15(3):162-74. doi: 10.1111/pedi.12148.
PubMed 24827702
Walker WA. Initial intestinal colonization in the human infant and immune homeostasis. Ann Nutr Metab. 2013;63 Suppl 2:8-15. doi: 10.1159/000354907. Epub 2013 Nov 8.
PubMed 24217032
Kemppainen KM, Ardissone AN, Davis-Richardson AG, Fagen JR, Gano KA, Leon-Novelo LG, Vehik K, Casella G, Simell O, Ziegler AG, Rewers MJ, Lernmark A, Hagopian W, She JX, Krischer JP, Akolkar B, Schatz DA, Atkinson MA, Triplett EW; TEDDY Study Group. Early childhood gut microbiomes show strong geographic differences among subjects at high risk for type 1 diabetes. Diabetes Care. 2015 Feb;38(2):329-32. doi: 10.2337/dc14-0850. Epub 2014 Dec 17.
PubMed 25519450
Kostic AD, Gevers D, Siljander H, Vatanen T, Hyotylainen T, Hamalainen AM, Peet A, Tillmann V, Poho P, Mattila I, Lahdesmaki H, Franzosa EA, Vaarala O, de Goffau M, Harmsen H, Ilonen J, Virtanen SM, Clish CB, Oresic M, Huttenhower C, Knip M; DIABIMMUNE Study Group; Xavier RJ. The dynamics of the human infant gut microbiome in development and in progression toward type 1 diabetes. Cell Host Microbe. 2015 Feb 11;17(2):260-73. doi: 10.1016/j.chom.2015.01.001. Epub 2015 Feb 5.
PubMed 25662751
Zeitlin J, Szamotulska K, Drewniak N, Mohangoo AD, Chalmers J, Sakkeus L, Irgens L, Gatt M, Gissler M, Blondel B; Euro-Peristat Preterm Study Group. Preterm birth time trends in Europe: a study of 19 countries. BJOG. 2013 Oct;120(11):1356-65. doi: 10.1111/1471-0528.12281. Epub 2013 May 24.
PubMed 23700966
Soll RF, Edwards WH. Antibiotic use in neonatal intensive care. Pediatrics. 2015 May;135(5):928-9. doi: 10.1542/peds.2015-0707. No abstract available.
PubMed 25896842
Li S, Zhang M, Tian H, Liu Z, Yin X, Xi B. Preterm birth and risk of type 1 and type 2 diabetes: systematic review and meta-analysis. Obes Rev. 2014 Oct;15(10):804-11. doi: 10.1111/obr.12214. Epub 2014 Jul 30.
PubMed 25073871
Cardwell CR, Carson DJ, Patterson CC. Parental age at delivery, birth order, birth weight and gestational age are associated with the risk of childhood Type 1 diabetes: a UK regional retrospective cohort study. Diabet Med. 2005 Feb;22(2):200-6. doi: 10.1111/j.1464-5491.2005.01369.x.
PubMed 15660739
Crump C, Winkleby MA, Sundquist K, Sundquist J. Risk of diabetes among young adults born preterm in Sweden. Diabetes Care. 2011 May;34(5):1109-13. doi: 10.2337/dc10-2108. Epub 2011 Mar 16.
PubMed 21411504

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Type 1 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02929953
Acronym / sponsor ID: T1Dpremies / 183/13
Conditions: Type 1 Diabetes Mellitus
Keywords: premature birth, risk factor, type 1 diabetes mellitus, seasonality, prevalence, enteral feeding, immunomodulating medications, early onset
Study type: Observational
Recruitment status: Completed
Enrolment: 3,600 participants (estimated)
Lead sponsor: Assaf Harofeh MCOther government
Collaborators: Shaare Zedek Medical Center, Wolfson Medical Center, Ziv Medical Center, Schneider Children's Medical Center, Israel, Tel-Aviv Sourasky Medical Center, Maccabi Healthcare Services, Israel, Kaplan Medical Center, HaEmek Medical Center, Israel, Soroka University Medical Center, Rambam Health Care Campus, Hadassah Medical Organization
Study start: Jan 2014
Primary completion: Apr 2019 (actual)
Study completion: Apr 2019 (actual)
First posted: 11 Oct 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aims of this study are:

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.
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

In the latter part of the study, a multi-centered, paired case-control study is performed.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Diabetes mellitus type 1	–	Other: chart reviewall T1DM patients in Israel, born during 2000-2013 and diagnosed prior to January 2015. chart review
Non-diabetic	–	Other: chart reviewnon-diabetic general population born in Israel during 2000-2013, according to the Israeli Health Ministry's Birth Registry (IHMBR) chart review

Who may qualify

Ages: 1 year to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

Lack of birth data
Unknown type of diabetes
For case control portion, an incomplete medical record/inadequate documentation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
chart reviewdata from charts and from registries will be compared	Other	Diabetes mellitus type 1, Non-diabetic

Primary outcome

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

2 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
Background: PubMed 24283719Blumenfeld O, Dichtiar R, Shohat T; Israel IDDM Registry Study Group (IIRSG). Trends in the incidence of type 1 diabetes among Jews and Arabs in Israel. Pediatr Diabetes. 2014 Sep;15(6):422-7. doi: 10.1111/pedi.12101. Epub 2013 Nov 27.
Background: PubMed 23733895Egro FM. Why is type 1 diabetes increasing? J Mol Endocrinol. 2013 Jul 12;51(1):R1-13. doi: 10.1530/JME-13-0067. Print 2013.
Background: PubMed 22261289De Curtis M, Rigo J. The nutrition of preterm infants. Early Hum Dev. 2012 Mar;88 Suppl 1:S5-7. doi: 10.1016/j.earlhumdev.2011.12.020. Epub 2012 Jan 17.
Background: PubMed 24231027Working Group Of Pediatrics Chinese Society Of Parenteral And Enteral Nutrition, Working Group Of Neonatology Chinese Society Of Pediatrics, Working Group Of Neonatal Surgery Chinese Society Of Pediatric Surgery. CSPEN guidelines for nutrition support in neonates. Asia Pac J Clin Nutr. 2013;22(4):655-63. doi: 10.6133/apjcn.2013.22.4.21.
Background: PubMed 25883958Kagohashi Y, Otani H. Role of nutritional factors at the early life stages in the pathogenesis and clinical course of type 1 diabetes. Biomed Res Int. 2015;2015:382165. doi: 10.1155/2015/382165. Epub 2015 Mar 26.
Background: PubMed 21376535Ziegler AG, Pflueger M, Winkler C, Achenbach P, Akolkar B, Krischer JP, Bonifacio E. Accelerated progression from islet autoimmunity to diabetes is causing the escalating incidence of type 1 diabetes in young children. J Autoimmun. 2011 Aug;37(1):3-7. doi: 10.1016/j.jaut.2011.02.004. Epub 2011 Mar 3.
Background: PubMed 24827702Jaberi-Douraki M, Liu SW, Pietropaolo M, Khadra A. Autoimmune responses in T1DM: quantitative methods to understand onset, progression, and prevention of disease. Pediatr Diabetes. 2014 May;15(3):162-74. doi: 10.1111/pedi.12148.
Background: PubMed 24217032Walker WA. Initial intestinal colonization in the human infant and immune homeostasis. Ann Nutr Metab. 2013;63 Suppl 2:8-15. doi: 10.1159/000354907. Epub 2013 Nov 8.
Background: PubMed 25519450Kemppainen KM, Ardissone AN, Davis-Richardson AG, Fagen JR, Gano KA, Leon-Novelo LG, Vehik K, Casella G, Simell O, Ziegler AG, Rewers MJ, Lernmark A, Hagopian W, She JX, Krischer JP, Akolkar B, Schatz DA, Atkinson MA, Triplett EW; TEDDY Study Group. Early childhood gut microbiomes show strong geographic differences among subjects at high risk for type 1 diabetes. Diabetes Care. 2015 Feb;38(2):329-32. doi: 10.2337/dc14-0850. Epub 2014 Dec 17.
Background: PubMed 25662751Kostic AD, Gevers D, Siljander H, Vatanen T, Hyotylainen T, Hamalainen AM, Peet A, Tillmann V, Poho P, Mattila I, Lahdesmaki H, Franzosa EA, Vaarala O, de Goffau M, Harmsen H, Ilonen J, Virtanen SM, Clish CB, Oresic M, Huttenhower C, Knip M; DIABIMMUNE Study Group; Xavier RJ. The dynamics of the human infant gut microbiome in development and in progression toward type 1 diabetes. Cell Host Microbe. 2015 Feb 11;17(2):260-73. doi: 10.1016/j.chom.2015.01.001. Epub 2015 Feb 5.
Background: PubMed 23700966Zeitlin J, Szamotulska K, Drewniak N, Mohangoo AD, Chalmers J, Sakkeus L, Irgens L, Gatt M, Gissler M, Blondel B; Euro-Peristat Preterm Study Group. Preterm birth time trends in Europe: a study of 19 countries. BJOG. 2013 Oct;120(11):1356-65. doi: 10.1111/1471-0528.12281. Epub 2013 May 24.
Background: PubMed 25896842Soll RF, Edwards WH. Antibiotic use in neonatal intensive care. Pediatrics. 2015 May;135(5):928-9. doi: 10.1542/peds.2015-0707. No abstract available.
Individual participant dataSharing planned: No. IPD data will not be available for anyone other than the PI and co-investigators.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

marianna Rachmiel, md principal investigator

Assaf Haroffeh Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes Mellitus, run by Assaf Harofeh MC at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

prematurity prevalence among T1D patients (time frame: 1 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02929953, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.