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Article History

Received: 4 October 2019

Accepted: 17 October 2019

First Online: 7 November 2019

Ethics approval and consent to participate

: The NHS Research Ethics Committee West Midlands - Edgbaston has provided ethical approval for the conduct of this study (REC reference: CitationRef removed/WM/0036). HRA Approval was issued on 05 February 2018.All methods of consent were approved by the Ethics Committee. The Caldicott Guardian of each participating practice gave to consent to the data extraction from primary care. Return of a completed questionnaire will be taken as implied consent. Patients will also be asked to provide written consent for the research team to link their responses to the data extracted from GP practices and their record held by the local SSME Provider, if such a record exists. Additionally, consent will be taken by the researcher before to the start of the interview or the observation.The current protocol version is Version 3; 23 April 2019. Two substantial amendments have been approved. Substantial Amendment 1 changes were based on feasibility study findings and entailed a revision of sample size, study paperwork and how data is collected. Substantial Amendment 2 involved changes to practice eligibility criteria, to clarify that ethnographic sub-study is optional and to increase study target, due to the greater than anticipated number of questionnaires being returned by patients.

: Not applicable.

: Conflicts of interest: We do not hold any conflicts of interest, however, for transparency we provide the following statement of conflict: MJD is the Principal Investigator (PI) on the DESMOND programme (Diabetes education and self-management for people with newly diagnosed Type 2 diabetes). BS, SS and AN are employed by the University Hospitals of Leicester NHS Trust, which receives not-for-profit income for DESMOND. MJD, KK, HE, LG, AN, SS and BS are actively engaged in research and have previously received grants for DESMOND from NIHR, MRC and Diabetes UK to develop and test Diabetes Self-Management Education and Support programmes like DESMOND. The University Hospitals of Leicester (UHL) NHS Trust (for which BS, SS and AN have a contract) receives licensing fees to support implementation of the DESMOND programme in CCGs in the UK, Ireland and Australia.All other authors have no competing interests.