Diabetes Mellitus, Type 1INGR1DNCT03503747
Investigating Genetic Risk for Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 4 months
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Glucose Metabolism Disorders
- How many people
- 15,640 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Apr 2018to 31 Aug 2021
- 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 0 to 4 months
- All sexes
- Child
Study population: The study will include all infants where the mother has consented to the additional screening test being performed.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This is a population screening study to undertake (with prospective consent) additional testing of the newborn screening blood to identify children at increased genetic risk of type 1 diabetes. This study will enrol newborn babies whose mothers have given consent to additional testing for the newborn blood screening (routinely performed when the baby is approximately 5 days old).
Women will be approached by research staff in the second or third trimester of pregnancy (≥18 weeks gestation) when attending for antenatal care. At this point, the study will be discussed with the woman and if interested a patient information sheet will be provided as well as the opportunity to ask questions. If they agree to participate, a qualified member of the research team will take written informed consent. This consent will allow a) completion of a questionnaire and b) prospective consent to use the surplus neonatal screening blood sample for genetic testing.
The punch from the blood sample will analysed for the child's risk of type 1 diabetes. If found to be at high risk (>10%) they will be contacted by a member of the clinical study team to discuss the results and invite them to participate in a phase II prevention trial.
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Autoimmune Diseases
- Keywords
- type 1 diabetes, Infants, INGR1D
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: February 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start25 Apr 2018
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- 15,640 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503747
- Sponsor's protocol ID
- OVG 2017/09
- Acronym
- INGR1D
- Status last verified
- Dec 2020
- First submitted
- 30 Jan 2018
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Genetic Risk for Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03503747
- Acronym / sponsor ID
- INGR1D / OVG 2017/09
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Autoimmune Diseases
- Keywords
- type 1 diabetes, Infants, INGR1D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,640 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 20 Apr 2018 (actual)
- 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 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.
Detailed description
This is a population screening study to undertake (with prospective consent) additional testing of the newborn screening blood to identify children at increased genetic risk of type 1 diabetes. This study will enrol newborn babies whose mothers have given consent to additional testing for the newborn blood screening (routinely performed when the baby is approximately 5 days old).
Women will be approached by research staff in the second or third trimester of pregnancy (≥18 weeks gestation) when attending for antenatal care. At this point, the study will be discussed with the woman and if interested a patient information sheet will be provided as well as the opportunity to ask questions. If they agree to participate, a qualified member of the research team will take written informed consent. This consent will allow a) completion of a questionnaire and b) prospective consent to use the surplus neonatal screening blood sample for genetic testing.
The punch from the blood sample will analysed for the child's risk of type 1 diabetes. If found to be at high risk (>10%) they will be contacted by a member of the clinical study team to discuss the results and invite them to participate in a phase II prevention trial.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 0 to 4 months
- Sex
- All
- Age groups
- Child
- Study population
- The study will include all infants where the mother has consented to the additional screening test being performed.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantification of the number of participants with high-risk genetic markers for the development of type 1 diabetes.
Time frame: February 2021
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.
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 24 Sep 2021.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetes Mellitus, Type 1 and Diabetes Mellitus, run by University of Oxford at 1 site in United Kingdom.
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 2 inclusion and 2 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 24 Sep 2021. 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 United Kingdom. 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?
Quantification of the number of participants with high-risk genetic markers for the development of type 1 diabetes. (time frame: February 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2021; AzTrials last refreshed its copy on 31 Oct 2026.