Characterising new-onset type 1 diabetes and supporting type 1 diabetes research
| ISRCTN | ISRCTN66496918 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66496918 |
| IRAS number | 55225 |
| Secondary identifying numbers | CPMS 9689, IRAS 55225 |
- Submission date
- 16/10/2017
- Registration date
- 08/03/2018
- Last edited
- 16/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Diabetes is a life-long condition that causes a person’s blood sugar to become uncontrolled and too high. This condition usually forms while someone is young. There are similarities in the presentation of type 1 diabetes, for example, similarities in some symptoms, but there are also many differences. An up-to-date picture of type 1 diabetes at onset in children and adults in modern and diverse Britain is needed to improve understanding of these similarities and differences. There are other studies that are investigating ways of preserving beta cell function soon after diagnosis, but finding people to take part in these studies can be challenging. The aim of this study is to help to put people interested in taking part in research in touch with researchers running studies. It also supports other research by making the anonymous information blood and DNA samples collected in the study, available to other researchers.
Who can participate?
Children aged from 5 years and adults of any age who have had type 1 diabetes for less than 6 months. Siblings without diabetes can also participate.
What does the study involve?
Participants have an interview with a researcher to collect information about medication, medical history and family history and onset of diabetes (not siblings). An optional blood sample for testing and storage of blood and DNA is taken from participants. Participants allow the study team to collect health information from medical records and from central NHS systems. Participants are asked to consent to being contacted about other diabetes research, but are under no obligation to take part in other research. They are also asked to consent to the sharing of their anonymous information and biological samples for other research relevant to diabetes.
What are the possible benefits and risks of participating?
There is no direct benefit to participants. An improved understanding of type 1 diabetes at onset may lead to benefits for people with type 1 diabetes in the future. Giving a blood sample has a risk of bruising and discomfort.
Where is the study run from?
This study is being run by Imperial College London (UK) and takes place in hospitals across the UK.
When is the study starting and how long is it expected to run for?
July 2010 to April 2025
Who is funding the study?
Diabetes UK (UK)
(Note: Juvenile Diabetes Research Foundation Limited (JDRF) (UK) funded between July 2010 to December 2018)
Who is the main contact?
Ms Akaal Kaur
address-2@imperial.ac.uk
Contact information
Scientific
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United Kingdom
| Phone | +44 |
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| address2@imperial.ac.uk |
Study information
| Study design | Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | The patient information sheets are available on the study website https://www.address2.org |
| Scientific title | An incident and high risk type 1 diabetes research cohort - After Diagnosis Diabetes REsearch Support System-2 (ADDRESS-2) |
| Study acronym | ADDRESS-2 |
| Study hypothesis | The aim of this study is to characterise new-onset type 1 diabetes in the modern and diverse UK population. To link people wanting to participate in type 1 diabetes research with researchers and studies. To support other type 1 diabetes research via an open access repository of data and biological samples. |
| Ethics approval(s) | Approved 03/10/2010, South Central – Berkshire NHS Research Ethics Committee (Bristol HRA Centre, Bristol, BS1 2NT, United Kingdom; +44 (0)207 104 8178; berkshire.rec@hra.nhs.uk), ref: 10/H0505/85 |
| Condition | Type 1 diabetes mellitus |
| Intervention | Demographic, clinical and routine laboratory data are collected via interview with participants and from their medical records at a single study visit. An optional blood sample is collected for the measurement of islet autoantibodies (markers of autoimmune activity in type 1 diabetes), extraction and storage of DNA and storage of blood. Within the first year of diagnosis, follow-up data are collected from medical records to confirm or record a change in diabetes sub-type. |
| Intervention type | Other |
| Primary outcome measure | Autoantibody status is measured in a single laboratory using established radiobinding assays at baseline and characteristics at presentation are measured using patient interviews, medical records and pathology systems at baseline. |
| Secondary outcome measures | There are no secondary outcome measures. |
| Overall study start date | 01/07/2010 |
| Overall study end date | 31/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 1 Year |
| Sex | Both |
| Target number of participants | Planned Sample Size: 10,000; UK Sample Size: 10,000 |
| Participant inclusion criteria | Current inclusion criteria as of 29/08/2024: 1. Age ≥1 years 2. Male or female 3. Clinical diagnosis of type 1 diabetes or unclassified but possible type 1 diabetes and have been diagnosed less than 6 months at the time of recruitment or the sibling of someone meeting the criteria above who has consented to the study. Sibling must be free from diabetes Previous inclusion criteria: 1. Age ≥5 years 2. Male or female 3. Clinical diagnosis of type 1 diabetes or unclassified but possible type 1 diabetes and have been diagnosed less than 6 months at the time of recruitment or the sibling of someone meeting the criteria above who has consented to the study. Sibling must be free from diabetes |
| Participant exclusion criteria | Current exclusion criteria as of 29/08/2024: 1. Children under 1 years of age 2. Individuals aged 16 years or older who are not competent to give consent 3. Recently diagnosed type 1 diabetes participants, who have been previously diagnosed with type 2 diabetes, unless the initial diagnosis of type 2 diabetes is also within 6 months prior to enrolment Previous exclusion criteria: 1. Children under 5 years of age. 2. Individuals aged 16 years or older who are not competent to give consent. 3. Recently diagnosed type 1 diabetes participants, who have been previously diagnosed with type 2 diabetes, unless the initial diagnosis of type 2 diabetes is also within 6 months prior to enrolment |
| Recruitment start date | 01/07/2011 |
| Recruitment end date | 31/03/2026 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centre
London
W6 8RF
United Kingdom
Sponsor information
University/education
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United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
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Funders
Funder type
Government
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- DIABETES UK LIMITED, British Diabetic Association
- Location
- United Kingdom
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Juvenile Diabetes Research Foundation Ltd, JUVENILE DIABETES RESEARCH FOUNDATION LIMITED, JDRF UK, JDRF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2024 |
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| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 25/03/2020: The protocol has been published: https://www.ncbi.nlm.nih.gov/pubmed/28706084. Preliminary results have been published: https://www.ncbi.nlm.nih.gov/pubmed/29622578. Planned publications of sub-analyses in 2020 and beyond. Previous publication and dissemination plan: The protocol has been published: https://www.ncbi.nlm.nih.gov/pubmed/28706084. Planned publication in a high-impact peer-reviewed journal. Intention to publish preliminary results early in 2018, followed by subsequent publications in 2019 and beyond. |
| IPD sharing plan | The datasets generated during the current study and stored DNA and blood samples are available upon application to the ADDRESS-2 Management Committee. The datasets include demographic, clinical and laboratory data. The access procedures and application forms are available on the study website (https://www.address2.org). Enquiries should be addressed to Ms Akaal Kaur (address2@imperial.ac.uk). Consent was obtained from participants for their anonymous data and biological samples to be shared for diabetes research. The research must have independent ethical approval and the approval of the ADDRESS-2 Management Committee. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 12/07/2017 | Yes | No | |
| Results article | results | 04/04/2018 | Yes | No |
Editorial Notes
16/04/2025: The recruitment end date and the overall study end date were changed from 30/04/2025 to 31/03/2026.
29/08/2024: The following changes were made to the study record:
1. IRAS number and ethics approval details added.
2. The inclusion and exclusion criteria were updated.
3. The target number of participants was changed from 6180 to 10,000.
4. The recruitment end date was changed from 31/07/2023 to 30/04/2025.
5. The overall study end date was changed from 30/04/2024 to 30/04/2025.
18/07/2023: The following changes were made to the trial record:
1. The overall end date was changed from 31/07/2023 to 30/04/2024.
2. Northern Ireland, Scotland, and Wales were added to the countries of recruitment.
22/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 31/07/2023.
2. The overall end date was changed from 31/12/2022 to 31/07/2023.
3. The intention to publish date was changed from 01/07/2021 to 31/07/2024.
4. The plain English summary was updated to reflect these changes.
20/09/2021: Internal review.
23/06/2020: The recruitment has resumed.
25/03/2020: The following changes were made to the trial record:
1. Due to current public health guidance, recruitment for this study has been paused.
2. The recruitment end date was changed from 31/12/2018 to 31/12/2022.
3. The overall trial end date was changed from 31/12/2019 to 31/12/2022.
4. Study contact and publication and dissemination plan updated.
26/06/2019: The intention to publish date was changed from 01/12/2019 to 01/07/2021.
28/02/2019: Publication reference added.
