Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/10/2017
Date assigned
08/03/2018
Last edited
08/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 2019

Who is funding the study?
1. Diabetes UK (UK)
2. Juvenile Diabetes Research Foundation Limited (JDRF) (UK)

Who is the main contact?
Dr Helen Walkey
address-2@imperial.ac.uk

Trial website

http://www.address2.org/

Contact information

Type

Scientific

Primary contact

Dr Helen Walkey

ORCID ID

http://orcid.org/0000-0003-3391-0759

Contact details

-
-
-
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9689

Study information

Scientific title

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

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

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

Study design

Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

The patient information sheets are available on the study website www.address2.org.

Condition

Specialty: Diabetes, Primary sub-specialty: Type 1; UKCRC code/ Disease: Metabolic and Endocrine/ 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

Phase

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

01/07/2010

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

01/07/2011

Recruitment end date

31/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Imperial College of Science, Technology and Medicine

Sponsor details

-
-
-
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Diabetes UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Juvenile Diabetes Research Foundation

Alternative name(s)

Juvenile Diabetes Research Foundation Ltd, JDRF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

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. The protocol has been published: https://www.ncbi.nlm.nih.gov/pubmed/28706084

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 www.address2.org. Enquiries should be addressed to Dr Helen Walkey 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.

Intention to publish date

01/12/2019

Participant level data

Stored in repository

Basic results (scientific)

Publication list

2017 protocol in https://www.ncbi.nlm.nih.gov/pubmed/28706084

Publication citations

Additional files

Editorial Notes