Rationale and protocol for the After Diabetes Diagnosis REsearch Support System (ADDRESS): an incident and high risk type 1 diabetes UK cohort study.
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Published version
Author(s)
Type
Journal Article
Abstract
INTRODUCTION: Type 1 diabetes is heterogeneous in its presentation and progression. Variations in clinical presentation between children and adults, and with ethnic group warrant further study in the UK to improve understanding of this heterogeneity. Early interventions to limit beta cell damage in type 1 diabetes are undergoing evaluation, but recruitment is challenging. The protocol presented describes recruitment of people with clinician-assigned, new-onset type 1 diabetes to understand the variation in their manner of clinical presentation, to facilitate recruitment into intervention studies and to create an open-access resource of data and biological samples for future type 1 diabetes research. METHODS AND ANALYSIS: Using the National Institute for Health Research Clinical Research Network, patients >5 years of age diagnosed clinically with type 1 diabetes (and their siblings) are recruited within 6 months of diagnosis. Participants agree to have their clinical, laboratory and demographic data stored on a secure database, for their clinical progress to be monitored using information held by NHS Digital, and to be contacted about additional research, in particular immunotherapy and other interventions. An optional blood sample is taken for islet autoantibody measurement and storage of blood and DNA for future analyses. Data will be analysed statistically to describe the presentation of incident type 1 diabetes in a contemporary UK population. ETHICS AND DISSEMINATION: Ethical approval was obtained from the independent NHS Research Ethics Service. Results will be presented at national and international meetings and submitted for publication to peer-reviewed journals.
Date Issued
2017-07-01
Date Acceptance
2017-06-06
Citation
BMJ Open, 2017, 7 (7)
ISSN
2044-6055
Publisher
BMJ Journals
Journal / Book Title
BMJ Open
Volume
7
Issue
7
Copyright Statement
© 2017 Article author(s) (or their employer(s) unless otherwise stated in the text of the article). All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Sponsor
Diabetes UK
Juvenile Diabetes Research Foundation International
Diabetes UK
Juvenile Diabetes Research Foundation Ltd (JDRF)
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/28706084
PII: bmjopen-2016-013956
Grant Number
09/0003919/PO-10138
9-2010-407
15/0005234
3-SRA-2015-36-A-N
Subjects
cohort study
incident type 1 diabetes
open access resource
phenotyping, biobank
Publication Status
Published
Coverage Spatial
England
Article Number
e013956