NCT02184676

Brief Summary

The purpose of this study is to determine whether early immunological markers (activation of autoreactive T lymphocytes) precede and are predictive of the appearance of autoantibodies in children born from type 1 diabetic parents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

May 28, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2019

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

4 years

First QC Date

July 3, 2014

Last Update Submit

December 4, 2025

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesrisk assessmentimmunological markerchildrenrelativesautoantibodieslymphocytesT cellsepitopesChildren born to mother/father with type 1 diabetes and their parents

Outcome Measures

Primary Outcomes (1)

  • Autoreactive T lymphocytes

    presence, frequency, antigen specificity, phenotype

    48 months

Secondary Outcomes (4)

  • Metagenomic signatures

    48 months

  • Metabolic signatures

    48 months

  • Environmental factors

    48 months

  • Incidence of autoantibodies

    48 months

Study Arms (1)

Children born to mother/father with type 1 diabetes

OTHER
Biological: Analysis of early immune modificationsOther: Collection of clinical and socio-demographic data

Interventions

Analysis of early immune modificationsBIOLOGICAL

* blood and stool sampling in parents during pregnancy (at enrollment, i.e. 7th-8th month of pregnancy) * cord blood sampling * stool sampling in mothers and newborns at birth (day 7) * blood and stool sampling in children at the age of 8, 18, 30 and 42 months

Children born to mother/father with type 1 diabetes
Collection of clinical and socio-demographic dataOTHER

1. Questionnaire filled in by clinicians at enrollment and at birth 2. Self-administered questionnaire filled by parents at enrollment, at birth, and then at month 8, 18, 30 and 42

Children born to mother/father with type 1 diabetes

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mother and/or father with type 1 diabetes
  • age \> 18 years
  • type 1 diabetes : insulin-dependent diabetes positive for autoantibodies against insulin and/or GAD and/or IA-2 and/or ZnT8 at the time of diagnosis
  • planning to give birth or having given birth since less than 8 months
  • agreeing to participate upon written informed consent
  • covered by the French social security system
  • Mother/father without Type 1 diabetes
  • age \> 18 years old
  • with a spouse with type 1 diabetes : insulin-dependent diabetes positive for autoantibodies against insulin and/or GAD and/or IA-2 and/or ZnT8 at the time of diagnosis
  • planning to give birth or having given birth since less than 8 months
  • agreeing to participate upon written informed consent
  • covered by the French social security system
  • Children born to mother and/or father with type 1 diabetes
  • age \< 8 months
  • with at least one parent with T1D
  • +2 more criteria

You may not qualify if:

  • \) Mother/father
  • secondary forms of diabetes
  • monogenic forms of diabetes
  • or 2) For the mother
  • malignant neoplastic or psychiatric disease
  • ) Newborns of mother/father with type 1 diabetes
  • Severe foetal disease
  • Severe congenital malformation
  • Congenital measles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Roberto Mallone, M.D, Ph.D.

    INSERM U1016

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 9, 2014

Study Start

May 28, 2015

Primary Completion

May 17, 2019

Study Completion

May 17, 2019

Last Updated

December 11, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)