Dr Robert EJ Ryder
Consultant Diabetologist, Clinical Lead, ABCD nationwide audits, City Hospital, Birmingham, UK
March 2014 sees, in the same month, two significant milestones for the Association of British Clinical Diabetologists (ABCD). The first is the launch of its own journal as it takes over the British Journal of Diabetes & Vascular Disease in the current issue.1 The second is the establishment of ABCD’s presence on N3 with the launch of the ABCD nationwide exenatide QW audit.
N3 is the national broadband network for the National Health Service (NHS), connecting all NHS locations, in particular linking acute hospitals and GP surgeries. The important thing from ABCD’s point of view is that it is the official secure place for storing NHS patient data and therefore the most appropriate and secure place for holding our nationwide audit data in the future.
ABCD has undertaken a number of nationwide audits since 2004.2 However it was really the ABCD nationwide exenatide audit,2 followed by the still on-going nationwide liraglutide audit,2 which established the pattern for the future. The nationwide exenatide audit collected data on 6,717 patients from 315 contributors and 126 centres. As of January 2014 the liraglutide audit had 6,213 patients from 117 centres and 550 contributors. From these audits we learned much. For example, that patients in the UK treated with exenatide and liraglutide were heavier and more poorly controlled than patients in the clinical trials of these agents.3 That the agents were often used off licence and outside of NICE guidelines, in particular with insulin; we were able to establish that in this situation they could be safe and effective.4,5 We demonstrated that it was safer to add the glucagon-like peptide-1 (GLP-1) receptor agonist to insulin and then tail off the insulin, rather than to discontinue the insulin at the commencement of exenatide or liraglutide in order to stay on licence or within guidelines, which could often be an unsafe thing to do.5 We were able to demonstrate that patients with professional driving licences achieved some success at avoiding insulin through the use of GLP-1 receptor agonists.6 We have been able to collate audit data on liraglutide use outside licence in mild renal impairment and report that efficacy has been preserved and no safety concerns reported.7 And most recently, we were able to contribute to the debate over whether GLP-1 related therapies might be associated with pancreatic damage – we found no such signal in our nationwide audits.8,9
For the nationwide exenatide audit an on-line tool built in-house was utilised. But because of insufficient security, users had to enter anonymised data with codes for each patient. The problem with that was that it required the user to keep a record of which codes represented which patient, which was very much less than ideal. For the liraglutide audit a professional tool was built, initially in the form of a sophisticated downloadable Excel spread sheet, but this was migrated in 2011 to an on-line tool in a secure area. Whilst this was sufficiently secure, using the same technology as used by banks, it was nevertheless less than the ideal place, the latter being N3. Thus ABCD embarked on a project to establish an on-line tool on N3 and this month sees the launch of that tool and ABCD’s presence on N3 for all such activities in the future.
The web-based tool on N310 is very easy to use. Centres may register to join the audit and designated contributors from each centre are each given individualised logons that give access to the on-line tool for their centre. The tool facilitates the collection of routine clinical information of patients at each of their visits. Centres may download their own data for local analysis and audit. However, their data are available at the same time in an anonymised form for the national audit. A sophisticated analysis tool has been built, such that the data can be grouped at intervals specified by whoever is analysing the data – for instance 2 monthly, 3 monthly, 4 monthly, 6 monthly, etc. The tool is so easy to use that data can be entered into the tool live in clinic, or alternatively it can collected onto paper proformas for entry into the tool later. The proformas can be printed from a downloadable PDF file, or there is a facility for ordering paper forms to be supplied by post. Whilst the audit is particularly for ABCD members, it is open to non-members and, indeed, anybody or centre using exenatide QW may join.
Future audits already agreed or under consideration include:
Nationwide dapagliflozin audit: This audit is particularly important with dapagliflozin being the first of a new class of drugs for diabetes, the Sodium/GLucose coTransporter 2 (SGLT2) inhibitors. As with the ABCD GLP-1 receptor agonist audits, it may be that patients being treated with the new class in real clinical practice will be different from those in clinical trials and outcomes may also be different both in terms of safety and efficacy. The audit is definitely going ahead and the questionnaire for the on-line tool is currently being developed. It will be hosted by ABCD on N3, as with the exenatide QW audit, and those taking part in the exenatide QW audit should find the process of the dapagliflozin audit very similar because of the similarity of the on-line tools. It is hoped that the dapagliflozin audit will launch as soon as the exenatide QW audit is well underway. It is also hoped that in due course the dapagliflozin audit will be enhanced by the Primary Care Diabetes Society joining in.
Nationwide degludec audit: This audit is in an advanced state of consideration. With many older established insulins in common usage, it will be important to try to gain insight into degludec in real clinical practice by attempting to record the routine data on all patients treated with this new insulin, if possible, so that the most accurate picture of it can be obtained. By pooling the data nationally we will hopefully learn more quickly from the shared experience. In clinical trials degludec was associated with less hypoglycaemia than other insulins and allowed for flexible dosing. The audit may give insight into whether these potential advantages translate in real clinical practice. The tool will be hosted on a tool very similar to that used in the liraglutide audit, so those taking part in that audit will find it particularly easy.
Possible nationwide lixisenatide audit: ABCD is giving consideration to such an audit given the fact that lixisenatide does seem to be different from some of the other GLP-1 receptor agonists, and it will be of interest and clinically useful to see how these differences translate in real clinical practice.
If yes, then please register for the nationwide audit, as described above, through http://www.diabetologists-abcd.org.uk/n3/ExenatideQW_Audit.htm. Please remember, if contributing, you will be able to analyse your local data easily, including use of the sophisticated tool for grouping the data. Also, all contributors will be listed in publications and presentations arising from data submission.
1. Walton C. Entering a new era. Br J Diabetes Vasc Dis 2014;14(1):1.
2. The history of the ABCD nationwide audit programme. Available at http://www.diabetologists-abcd.org.uk/n3/previous_ABCD_ audits.htm (2014, accessed 3 March 2014)
3. Ryder B, Thong K, the ABCD nationwide exenatide and nationwide liraglutide audit contributors. Findings from the Association of British Clinical Diabetologists (ABCD) nationwide exenatide and liraglutide audits. In Hot topics in diabetes, Vora J, ed. Synergy, London, 2012. Available at http://www.diabetologists-abcd.org.uk/GLP1_Audits/ABCD_Hot_Topics_2012.pdf (2012, accessed 3 March 2014)
4. Thong KY, Jose B, Sukumar N et al. Safety, efficacy and tolerability of exenatide in combination with insulin in the Association of British Clinical Diabetologists nationwide exenatide audit. Diab Obes Metab 2011;13: 703-10. http://dx.doi.org/10.1111/j.1463-1326.2011.01393.x
5. Thong KY, Jose B, Blann AD et al. Response at 3 months to insulin dose decisions made at exenatide initiation in the Association of British Clinical Diabetologists (ABCD) nationwide exenatide audit. Diab Res Clin Pract 2011;93:e87-91. http://dx.doi.org/10.1016/j.diabres.2011.05.015
6. Thong KY, Cull ML, Ryder REJ et al. Insulin avoidance and treatment outcomes among patients with a professional driving licence starting glucagon-like peptide 1 (GLP-1) agonists in the Association of British Clinical Diabetologists (ABCD) nationwide exenatide and liraglutide audits. Diabet Med 2012; 29(5):690-92. http://dx.doi.org/10.1111/j.1464-5491.2011.03475.x
7. Thong KY, Walton C, Ryder REJ, the ABCD nationwide liraglutide audit contributors. Safety and efficacy of liraglutide 1.2mg in patients with mild and moderate renal impairment:the ABCD nationwide liraglutide audit. Practical Diabetes 2013;30(2):71-6. http://dx.doi.org/10.1002/pdi.1748
8. Ryder REJ, Thong KY, Blann AD et al. Liraglutide pancreatitis: The ABCD nationwide liraglutide audit. Br J Diabetes Vasc Dis 2013;13:253-9. http://dx.doi.org/10.1177/1474651413502685
9. Ryder REJ, Sen Gupta P, Thong KY et al. The Association of British Clinical Diabetologists nationwide exenatide and liraglutide audits suggest a low incidence of acute pancreatitis. Response to Robson. Incretins and pancreatitis—what happens next? A personal viewpoint. Diabet Med 2013;30(12):1510-11. http://dx.doi.org/10.1111/dme.12336
10. ABCD nationwide exenatide QW audit on N3. Available at http://www.diabetologists-abcd.org.uk/n3/ExenatideQW_Audit.htm (2014, accessed 3 March 2014)
Address for correspondence:
Dr Bob Ryder, Diabetes and Endocrine Unit,
City Hospital, Dudley Road, Birmingham
B18 7QH, UK
E-mail: bob.ryder@nhs.net
Conflict of interest: REJR has received speaker fees, consultancy fees and/or educational sponsorship from a number of companies including in alphabetical order, Bristol Myers Squibb /Astra Zeneca Alliance, Eli Lilly, GlaxoSmithKline, Novo Nordisk, Sanofi-Aventis and Takeda.