Introduction & objectives Structured diabetes education (SDE) is an evidence-based intervention for type 2 diabetes. The goal of this study was to compare SDE whether accessed face to face or virtually and determine if any differences existed in key endpoint attainment. This study helps address the absence of evaluations comparing these access modalities.

Research design and methods All data were sourced from English SDE participants themselves, and their General Practices and routinely collected for service evaluation between 2016 and 2023. All data were observational, and all participants accessed usual care. The primary endpoint was the increase in the percentage of patients with glycated haemoglobin (HbA1c) at target [48mmol/mol (International Federation of Clinical Chemistry and Laboratory Medicine) / 6.5% (National Glycohemoglobin Standardization Program)] in virtually accessed SDE participants (V-SDE) versus face-to-face accessed SDE participants (F2F-SDE) on unchanged medicines for glycaemia. All data were non-normally distributed. Wilcoxon signed rank tests were used to analyse paired data, Mann-Whitney U-tests used for independent data and Chi-square tests used for observed versus expected data.

Results The 3,493 SDE participants with pre and post HbA1c data had a 10.2mmol/mol (16.4%) reduction in HbA1c, 389 days post their pre-SDE HbA1c measure. In the 2,334 (66.8%) participants who remained on the same medicines regime, the mean reduction in HbA1c was 9.1mmol/mol (15.2%), (p<0.001). All 617 V-SDE participants had a mean reduction in HbA1c of 13.6mmol/mol (20.9%) vs. 9.5mmol/mol (15.3%) in all 2,876 F2F-SDE participants, (p<0.001). The V-SDE on unchanged medicines had superior reductions in HbA1c to F2F-SDE (11.6 [n=404] vs. 8.6mmol/mol [n=1930], p=0.019), respectively. The overall increase in medicines for glycaemia was +12.45% F2F-SDE versus +4.21% V-SDE, (p<0.001).

The primary endpoint was the increase in the percentage of patients with HbA1c to target in V-SDE versus F2F-SDE in patients with unchanged medicines for glycaemia. Previous database analyses found a 30% increase in F2F-SDE patients at target who were on the same medicines regime. A non-inferiority limit was set at 10% for V-SDE versus F2F-SDE and required 360 patients per arm. The primary endpoint was attained with 52.2% of V-SDEs at target (+33.7%), versus the F2F-SDE gain of 29.6%. VSDE was not superior to F2F-SDE (p=0.16). Blood pressure, total cholesterol and weight were improved (all endpoints, p<0.001) with no differences between the interventions. Medicines use was unrecorded for these health endpoints.

Conclusions V-SDE met its non-inferiority goal, which was set in a population in which fewer V-SDE patients required increased medicines for glycaemia. These endpoints were subject to the limitations of unlinked, and routinely collected observational data.

All authors are employed by Spirit Health Group except for Professor Ghosh who had editorial control, access to and oversight of all data and analyses.

All services were delivered to patients in the included NHS Clinical Commissioning Groups and after organisational change by NHS Integrated Care Boards and paid for by the relevant NHS body. No authors were paid over and above their normal salaries for their contributions within their normal roles and no external contractors were paid for additional services. Professor Ghosh was not paid for his time in the oversight of the study design, analyses and its writing.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval was not required, as this was a service evaluation and was reviewed by De Montfort University Ethics Committee, decision reference FREC HLS 0976/23.

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Anonymised datasets will be made available to reasonable requests from academic institutions after publication in a peer reviewed journal.