Type 1 Diabetes (T1D)UKIAb RegistryNCT07125365
UK Islet Autoantibody Registry
An observational study of Type 1 Diabetes (T1D) and Registry, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Type 1 diabetes (T1D) is a life-long condition where the immune system destroys part of the body (the pancreas) which makes the chemical, insulin. Insulin is needed to control blood sugar levels. Treatment involves life-long insulin replacement by injection or insulin pump. Read more about this study
- Who is it for?
- Ages 6 months to 70 years
- Conditions the study is for
- Type 1 Diabetes (T1D), Registry, Pre-diabetes
- How many people
- 350 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jul 2025to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 months to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Potential participants will be identified via: * Established research platforms e.g. BOX, INNODIA, ADDRESS-2, PoINT, SINTIA, TrialNet, ELSA, T1DRA, (this is not an exhaustive list) * Referral from clinical care * Self-referral
Who may be able to join
- Male or female, aged 6 months - 70 years
- IAb positive (≥ 1) to any of the following: insulin/GAD/IA2/ZnT8, confirmed in a reference laboratory.
- Participant is willing and able to give informed consent for participation in the study (≥ 16 years old), or for < 16 years, parental/guardian consent (plus assent, where appropriate)
- Living in the UK
- For ADDRESS-2 participants only: have taken part in a blood draw as part of ADDRESS-2
- For the qualitative interviews: Have been living with (or is a parent/guardian of a child who has been living with) a positive IAb result for ≥ 6 months.
Who cannot join
- Ongoing subcutaneous insulin requirement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford
Oxford, Oxfordshire, OX3 7BN
UKIAb Study Coordinator, 07765932065, ukiab@ndm.ox.ac.uk
About this study
Type 1 diabetes (T1D) is a life-long condition where the immune system destroys part of the body (the pancreas) which makes the chemical, insulin. Insulin is needed to control blood sugar levels. Treatment involves life-long insulin replacement by injection or insulin pump.
Previous research has shown that the development of T1D occurs through different stages. This starts with a phase where there are no symptoms, which can last months or years, before symptoms of T1D develop and a person becomes unwell. The risk of developing T1D increases with presence of markers in the blood called islet autoantibodies. The risk of developing T1D increases with presence of markers in the blood called islet autoantibodies (IAb). Children with two or more IAb have an 80-90% chance of developing T1D within 15 years. It is almost certain that they will develop the condition in their lifetime. Children with only one IAb have a much lower risk of developing T1D (around 15%). Less is understood about the natural history of being IAb positive in adults, and the investigators hope this study will help them understand more.
Read more
The aim of the research is to understand what it is like to live with being at risk of T1D, what information and support people need, and whether they use NHS services more than others, for example due to being anxious about developing T1D. The investigators will work with the public and patient involvement group using information from the research and, with the charity Diabetes UK, to create a policy statement about the type of care that is needed to support these individuals.
To be able to do this research, tbhe investigators need first to recruit these rare individuals into one single registry of children, young people and adults who have islet autoantibodies in their blood. This will also allow the invetigators to collect data from individuals in the registry to compare this to data from other countries, to help understand why people progress from being islet autoantibody positive to requiring insulin in the UK.
People entering the registry will also be told if a drug is licensed in the UK to help delay T1D onset. Participants can also consent to be contacted about any research studies, which are testing drugs or interventions to prevent or delay the start of T1D.
Read the detailed description
BACKGROUND AND RATIONALE Type 1 diabetes can be identified in the pre-clinical phase Understanding of the natural history of Type 1 diabetes (T1D) has made it possible to diagnose children, young people and adults (CYPA) in the preclinical phase. The presence of ≥ 2 Islet autoantibodies (IAb) in serum, to 4 different proteins (insulin, Glutamic Acid Decarboxylase (GADA), insulinoma-2-associated autoantibodies (IA-2A), and/or zinc transporter 8 autoantibodies (ZnT8A) identifies individuals who will develop T1D. The latency period before clinical diagnosis can last months or years, with individuals with ≥2 IAb moving between stage 1 (normoglycaemia), stage 2 (dysglycaemia) to stage 3 (hyperglycaemia), or clinical disease.
Data from combined longitudinal cohorts shows that ≥ 2 IAb in children predicts that stage 3 T1D will develop in over 80% over the next 15 years, and near 100% over a lifetime, whereas only around 10-15% children with a single IAb progress to insulin requirement. Individuals may therefore live for many years with the knowledge they may develop T1D .
Potential benefits of early identification of T1D Identifying T1D before symptoms develop has several potential advantages, including reducing presentation with life-threatening diabetic ketoacidosis (DKA) and its associated morbidity, and potentially reducing the psychological trauma at diagnosis which some families liken to 'post-traumatic distress' . Reducing DKA and hospitalisations can also reduce associated health care costs. Screening identifies individuals suitable for trials to prevent or delay T1D. Therapies are now being trialled in stage 2 T1D, for example, the ATG prevention trial 'STOP-T1D'.
Concerns about screening Informing someone that they have positive IAb may cause psychological stress. For example, the Fr1da study, which has now tested > 170,000 children for IAb, found that informing parents of their child's positive IAb result induced stress (assessed by the Patient Health Questionnaire-9); this stress declined after 12 months of follow up. Within the registry, the investigators have recourse to the advice of a senior clinical psychologist, who can provide signposting support for individuals identified through the registry, if psychological concerns arise.
Screening initiatives Until recently, screening strategies have focussed on first-degree relatives (FDR) of individuals with T1D, who have a 15 times higher risk of developing stage 3 T1D compared to the general population. However, since > 85% of people with T1D do not have a family history, general population screening efforts have been started.
There are now several different screening programs in the UK identifying children, young people and adults with IAbs. It is anticipated that there are approximately 700 such children and adults from the different research platforms. These individuals do not typically present to their general practitioner as they have no symptoms, and therefore it is extremely rare to know of such individuals in the UK. Individuals can also be identified from clinical care (personal communication Besser \& Randell, BSPED). In order to answer our research questions, the investigators need a mechanism to identify, recruit and consent such individuals into a single combined registry.
- Conditions
- Type 1 Diabetes (T1D), Registry, Pre-diabetes, Screening
- Medical subject headings
- Diabetes Mellitus, Type 1, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| UKIAb | Children and adults aged 6 months - 70 years, positive for ≥ 1 islet autoantibody (IAb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of individuals enrolled on the registry
Measured: 36 months
Secondary outcomes (15)
Participants' perspectives and experiences
Interviews, to to understand the lived experience of being IAb positive or having a child who is IAb positive.
Measured: 28 months
Participants' perspectives and experiences
Interviews, to understand people's information and support needs when living with an IAb result, to improve the information and support given to people and their families who receive a positive T1D IAb result in the future and create a position statement informed by our findings.
Measured: 28 months
Frequency and risk factors (e.g. antibody profile, age) associated with clinical outcomes incident diabetes as defined by start of insulin use and number of DKA episodes
We will undertake data linkage with routinely collected NHS clinical datasets held by NHSE (and the equivalent for the devolved nations)
Measured: 28 months
Frequency and risk factors (e.g. antibody profile, age) associated with HbA1c mmol/l
To undertake data linkage with routinely collected NHS clinical datasets held by NHSE (and the equivalent for the devolved nations)
Measured: 28 months
Frequency of attendance in primary care
To assess the status of being IAb positive on health service usage and clinical outcomes using comparator cohorts (e.g. CPRD/HES)
Measured: 36 months
Frequency of attendance and inpatient admission to secondary/ tertiary care
To assess the status of being IAb positive on health service usage and clinical outcomes using comparator cohorts (e.g. CPRD/HES)
Measured: 36 months
IAb type (IA, IA-2, ZnT8, GAD, ICA)
To compare IAb characteristics to similar cohorts from international registries
Measured: 36 months
IAb laboratory (location)
To compare IAb characteristics to similar cohorts from international registries
Measured: 36 months
IAb titre (mULN)
To compare IAb characteristics to similar cohorts from international registries
Measured: 36 months
Demographic data
To compare demographic characteristics to similar cohorts from international registries
Measured: 36 months
Time to clinical diagnosis (defined as stage 3 T1D) according to standard diagnostic criteria
To assess risk of progression to stage 3 T1D in IAb positive individuals in the UK
Measured: 36 months
Number of individuals who have consented and enrolled to the registry
To assess consent to the registry vs enrolment
Measured: 36 months
IAb number (1-4)
To compare the proportion identified as confirmed positive from clinical care vs reference laboratories
Measured: 36 months
IAb type (IA-2, IA, ZnT8, GAD, ICA)
To compare the proportion identified as confirmed positive from clinical care vs reference laboratories
Measured: 36 months
IAb titre (mULM)
To compare the proportion identified as confirmed positive from clinical care vs reference laboratories
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start11 Jul 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies 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
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiff University, University of Edinburgh, University of Cambridge, University of Dundee, University of Birmingham, Imperial College London, University of Bristol, King's College London, Oxford University Hospitals NHS Trust, University of Exeter
- Responsible party
- Sponsor
- Investigators
- Rachel Besser, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125365
- Sponsor's protocol ID
- PID:18612
- Other IDs
- IRAS Project ID: 347853, REC reference: 25/SC/0089
- Acronym
- UKIAb Registry
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be considered for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UK Islet Autoantibody Registry
- ClinicalTrials.gov ID
- NCT07125365
- Acronym / sponsor ID
- UKIAb Registry / PID:18612
- Conditions
- Type 1 Diabetes (T1D), Registry, Pre-diabetes, Screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Cardiff University, University of Edinburgh, University of Cambridge, University of Dundee, University of Birmingham, Imperial College London, University of Bristol, King's College London, Oxford University Hospitals NHS Trust, University of Exeter
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 15 Aug 2025 (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.
Type 1 diabetes (T1D) is a life-long condition where the immune system destroys part of the body (the pancreas) which makes the chemical, insulin. Insulin is needed to control blood sugar levels. Treatment involves life-long insulin replacement by injection or insulin pump.
Previous research has shown that the development of T1D occurs through different stages. This starts with a phase where there are no symptoms, which can last months or years, before symptoms of T1D develop and a person becomes unwell. The risk of developing T1D increases with presence of markers in the blood called islet autoantibodies. The risk of developing T1D increases with presence of markers in the blood called islet autoantibodies (IAb). Children with two or more IAb have an 80-90% chance of developing T1D within 15 years. It is almost certain that they will develop the condition in their lifetime. Children with only one IAb have a much lower risk of developing T1D (around 15%). Less is understood about the natural history of being IAb positive in adults, and the investigators hope this study will help them understand more.
The aim of the research is to understand what it is like to live with being at risk of T1D, what information and support people need, and whether they use NHS services more than others, for example due to being anxious about developing T1D. The investigators will work with the public and patient involvement group using information from the research and, with the charity Diabetes UK, to create a policy statement about the type of care that is needed to support these individuals.
To be able to do this research, tbhe investigators need first to recruit these rare individuals into one single registry of children, young people and adults who have islet autoantibodies in their blood. This will also allow the invetigators to collect data from individuals in the registry to compare this to data from other countries, to help understand why people progress from being islet autoantibody positive to requiring insulin in the UK.
People entering the registry will also be told if a drug is licensed in the UK to help delay T1D onset. Participants can also consent to be contacted about any research studies, which are testing drugs or interventions to prevent or delay the start of T1D.
Detailed description
BACKGROUND AND RATIONALE Type 1 diabetes can be identified in the pre-clinical phase Understanding of the natural history of Type 1 diabetes (T1D) has made it possible to diagnose children, young people and adults (CYPA) in the preclinical phase. The presence of ≥ 2 Islet autoantibodies (IAb) in serum, to 4 different proteins (insulin, Glutamic Acid Decarboxylase (GADA), insulinoma-2-associated autoantibodies (IA-2A), and/or zinc transporter 8 autoantibodies (ZnT8A) identifies individuals who will develop T1D. The latency period before clinical diagnosis can last months or years, with individuals with ≥2 IAb moving between stage 1 (normoglycaemia), stage 2 (dysglycaemia) to stage 3 (hyperglycaemia), or clinical disease.
Data from combined longitudinal cohorts shows that ≥ 2 IAb in children predicts that stage 3 T1D will develop in over 80% over the next 15 years, and near 100% over a lifetime, whereas only around 10-15% children with a single IAb progress to insulin requirement. Individuals may therefore live for many years with the knowledge they may develop T1D .
Potential benefits of early identification of T1D Identifying T1D before symptoms develop has several potential advantages, including reducing presentation with life-threatening diabetic ketoacidosis (DKA) and its associated morbidity, and potentially reducing the psychological trauma at diagnosis which some families liken to 'post-traumatic distress' . Reducing DKA and hospitalisations can also reduce associated health care costs. Screening identifies individuals suitable for trials to prevent or delay T1D. Therapies are now being trialled in stage 2 T1D, for example, the ATG prevention trial 'STOP-T1D'.
Concerns about screening Informing someone that they have positive IAb may cause psychological stress. For example, the Fr1da study, which has now tested > 170,000 children for IAb, found that informing parents of their child's positive IAb result induced stress (assessed by the Patient Health Questionnaire-9); this stress declined after 12 months of follow up. Within the registry, the investigators have recourse to the advice of a senior clinical psychologist, who can provide signposting support for individuals identified through the registry, if psychological concerns arise.
Screening initiatives Until recently, screening strategies have focussed on first-degree relatives (FDR) of individuals with T1D, who have a 15 times higher risk of developing stage 3 T1D compared to the general population. However, since > 85% of people with T1D do not have a family history, general population screening efforts have been started.
There are now several different screening programs in the UK identifying children, young people and adults with IAbs. It is anticipated that there are approximately 700 such children and adults from the different research platforms. These individuals do not typically present to their general practitioner as they have no symptoms, and therefore it is extremely rare to know of such individuals in the UK. Individuals can also be identified from clinical care (personal communication Besser \& Randell, BSPED). In order to answer our research questions, the investigators need a mechanism to identify, recruit and consent such individuals into a single combined registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UKIAb | – | –Children and adults aged 6 months - 70 years, positive for ≥ 1 islet autoantibody (IAb) |
Who may qualify
- Ages
- 6 months to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Potential participants will be identified via: * Established research platforms e.g. BOX, INNODIA, ADDRESS-2, PoINT, SINTIA, TrialNet, ELSA, T1DRA, (this is not an exhaustive list) * Referral from clinical care * Self-referral
Key inclusion criteria (6 listed)
- Male or female, aged 6 months - 70 years
- IAb positive (≥ 1) to any of the following: insulin/GAD/IA2/ZnT8, confirmed in a reference laboratory.
- Participant is willing and able to give informed consent for participation in the study (≥ 16 years old), or for < 16 years, parental/guardian consent (plus assent, where appropriate)
- Living in the UK
- For ADDRESS-2 participants only: have taken part in a blood draw as part of ADDRESS-2
Key exclusion criteria (1 listed)
- Ongoing subcutaneous insulin requirement
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
Number of individuals enrolled on the registry
Time frame: 36 months
15 secondary outcomes
Participants' perspectives and experiences
Time frame: 28 months
Participants' perspectives and experiences
Time frame: 28 months
Frequency and risk factors (e.g. antibody profile, age) associated with clinical outcomes incident diabetes as defined by start of insulin use and number of DKA episodes
Time frame: 28 months
Frequency and risk factors (e.g. antibody profile, age) associated with HbA1c mmol/l
Time frame: 28 months
Frequency of attendance in primary care
Time frame: 36 months
Frequency of attendance and inpatient admission to secondary/ tertiary care
Time frame: 36 months
IAb type (IA, IA-2, ZnT8, GAD, ICA)
Time frame: 36 months
IAb laboratory (location)
Time frame: 36 months
IAb titre (mULN)
Time frame: 36 months
Demographic data
Time frame: 36 months
Time to clinical diagnosis (defined as stage 3 T1D) according to standard diagnostic criteria
Time frame: 36 months
Number of individuals who have consented and enrolled to the registry
Time frame: 36 months
IAb number (1-4)
Time frame: 36 months
IAb type (IA-2, IA, ZnT8, GAD, ICA)
Time frame: 36 months
IAb titre (mULM)
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD will be considered for data sharing.
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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.
Rachel Besser principal investigator
University of Oxford
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 (T1D) and Registry, 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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact UKIAb Registry Manager (+44(0)7765 932065, ukiab@ndm.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of individuals enrolled on the registry (time frame: 36 months). 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 15 Aug 2025.