Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

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 to 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 December 2022

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

Trial website

Contact information



Primary contact

Ms Akaal Kaur


Contact details

United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

An incident and high risk type 1 diabetes research cohort - After Diagnosis Diabetes REsearch Support System-2 (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

South Central – Berkshire NHS Research Ethics Committee, 03/10/2010, ref: 10/H0505/85

Study design

Observational; Design type: Cohort study

Primary study design


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet

The patient information sheets are available on the study website


Type 1 diabetes mellitus


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



Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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 type


Age group




Target number of participants

Planned Sample Size: 6180; UK Sample Size: 6180

Participant 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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Charing Cross Hospital (Lead Centre)
Fulham Palace Road
W6 8RF
United Kingdom

Sponsor information


Imperial College of Science, Technology and Medicine

Sponsor details

United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Diabetes UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations


United Kingdom

Funder name

Juvenile Diabetes Research Foundation

Alternative name(s)

Juvenile Diabetes Research Foundation Ltd, The Juvenile Diabetes Foundation (UK), JDRF, JDRF UK

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)


United Kingdom

Results and Publications

Publication and dissemination plan

Current publication and dissemination plan as of 25/03/2020:
The protocol has been published: Preliminary results have been published: Planned publications of sub-analyses in 2020 and beyond.

Previous publication and dissemination plan:
The protocol has been published: 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 statement:
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 ( Enquiries should be addressed to Ms Akaal Kaur ( 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.

Intention to publish date


Participant level data

Stored in repository

Basic results (scientific)

Publication list

1. 2017 protocol in
2. 2018 results in:

Publication citations

Additional files

Editorial Notes

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.