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.
- incident type 1 diabetes
- cohort study
- phenotyping, biobank
- open access resource
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Contributors The vision for an ascertainment network was that of DGJ in consultation with funders. Recruitment, data collection and analysis were designed and refined by DGJ, HCW, NO, VB, AK, SM and DBD. Islet autoantibody analysis was designed by PJB and AJKW. The statistical analysis plan was written by IFG. Procedures for open access were drafted by HCW and ratified by the ADDRESS-2 Management Committee.
Funding This work was supported by Diabetes UK grant number 09/0003919 and the Juvenile Diabetes Research Foundation grant number 9-2010-407. Recruitment is supported by staff at the National Institute for Health Research Clinical Research Network.
Competing interests None declared.
Ethics approval NHS Research Ethics Committee (South Central-Berkshire).
Provenance and peer review Not commissioned; externally peer reviewed.
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