NCT03503747

Brief Summary

The objective of this study is to determine the percentage of children with genetic markers putting them at increased risk of developing type 1 diabetes, and to offer the opportunity for these children to be enrolled into a phase II b primary prevention trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15,640

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

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

January 30, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

April 25, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

September 24, 2021

Status Verified

December 1, 2020

Enrollment Period

3.4 years

First QC Date

January 30, 2018

Last Update Submit

September 23, 2021

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseaseEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Keywords

type 1 diabetesInfantsINGR1D

Outcome Measures

Primary Outcomes (1)

  • Quantification of the number of participants with high-risk genetic markers for the development of type 1 diabetes.

    The number of children with a greater than 10% (high) risk of developing type 1 diabetes will be quantified, based on risk scores derived from SNPs that show the presence of HLA DR3, HLA DR4, and HLA DQ8 alleles as well as SNPs from HLA class I and non-HLA type 1 diabetes susceptibility genes, and from HLA class II protective alleles.

    February 2021

Eligibility Criteria

Age0 Months - 4 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study will include all infants where the mother has consented to the additional screening test being performed.

You may qualify if:

  • Parent/guardian of participant is willing and able to give informed consent for participation in the study.
  • Participant has provided blood for the newborn screening blood test, with sufficient sample remaining after routine testing.

You may not qualify if:

  • Parent/legal guardian unwilling or unable to give written informed consent to participate in the study
  • Unable to understand written or verbal English which would preclude them from understanding the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford University Hospitals NHS Trust

Oxford, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2018

First Posted

April 20, 2018

Study Start

April 25, 2018

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

September 24, 2021

Record last verified: 2020-12

Locations

GB(1)