The DiabetesFlex trial, conducted at Aarhus University Hospital, Denmark, sought to evaluate the effects and safety of switching to a more flexible model where people with type 1 diabetes could elect to replace some of their routine, face-to-face clinic visits with telephone calls or cancel them altogether.
A total of 320 adults with type 1 diabetes of >1 year’s duration (mean age 48 years; 74% with a diabetes duration >10 years) were evaluated and were randomised to either the flexible or standard care model. Both groups had face-to-face consultations at study initiation and at follow-up after 15 months. Between these clinics, the standard care group continued to have their routine, face-to-face consultations, with a doctor or diabetes specialist nurse, every 4 months, while the flexible group could choose whether to attend their clinics face to face or over the telephone, or to cancel them.
Two weeks prior to each consultation, participants in the flexible group completed a shortened version of the internet-based, diabetes-specific AmbuFlex questionnaire of patient-reported outcomes. This comprised 17 items, including clinical measurements (e.g. HbA1c and blood pressure), general health and wellbeing questions, diabetes distress, urgent diabetes complications, topics the patient wished to discuss and consultation preferences. Based on their responses, a specialist diabetes nurse evaluated whether it was safe to cancel the consultation or hold it remotely.
During the study, the mean number of visits was not markedly different in the two groups; however, the flexible group had 22% fewer face-to-face visits. It also had a greater proportion of face-to-face visits cancelled ahead of time (17% vs 8.7%) and fewer did-not-attends (2% vs 8%). At the end of the study, 94% of participants in the flexible group elected to continue with the model, and 54% of the standard care group chose to switch to flexible clinics.
At the final follow-up, mean HbA1c was similar between the two groups, as were blood pressure and lipid levels, and no participant had been hospitalised with severe hypoglycaemia or diabetic ketoacidosis. The flexible model was thus concluded to be safe. The specialist nurse judged the switch to telephone or cancelled appointment to be unsafe on four occasions.
Compared with the standard group, the flexible group had significant improvements in overall and diabetes wellbeing scores (mean WHO-5 index score increased by 4.5 [out of 100] points, while the mean Problem Areas In Diabetes score decreased by 4.8 [out of 100] points). While these improvements were statistically significant, they did not exceed the threshold for clinical relevance; however, the scores were already good at baseline, with WHO-5 scores similar to those of the general Danish population.
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Vinod Patel highlights the growing evidence base that lifestyle interventions are effective, and encourages persistence even though they can be difficult.
25 May 2023