Effectiveness of video consultations in type 1 diabetes patients treated with insulin pumps in the outpatient clinic: a randomised controlled trial.

aims/hypothesisThe aim of this work was to assess the effect of video consultations over 1 year compared with usual care for patients with type 1 diabetes treated with insulin pumps, with time in range (TiR) as the primary outcome measure.

methodsWe carried out a 52 week, open label, randomised, controlled superiority trial including adult type 1 diabetes patients treated with insulin pumps. Participants were recruited from the Hospital of Southern Jutland and were adult patients, diagnosed with type 1 diabetes mellitus who had used an insulin pump for at least 6 months. Participants were randomised to video consultations (intervention) or physical consultations (control) using a computer-generated block randomisation sequence in a 1:1 allocation, stratified for sensor type (continuous glucose monitor and flash glucose monitor, respectively).Since this was an 'open-label' trial, neither the healthcare professionals providing the treatment nor the participants were blinded to allocation after randomisation. The primary outcome measure was the percentage of TiR (glucose levels 3.9-10.0 mmol/l) from week 51 to 52, measured by continuous glucose monitoring. Continuous endpoints were analysed using ANCOVA, with randomised treatment and stratification groups as fixed effects and the baseline value as a covariate. Missing data in the intention-to-treat (ITT) population were addressed using multiple imputation.

resultsOf the 76 randomised participants (ITT population, 38 per group, median age 49 years, 51% women), 32 participants in the intervention group and 31 in the control group completed the study. Least square means TiR at 1 year was 64.3% in the video group and 63.5% in the control group, with a clinically insignificant difference of 0.8 percentage points (95% CI -5.3, 6.9; p=0.25). For secondary outcomes, the video group was superior in terms of treatment satisfaction and reduction in HbA CONCLUSIONS/

interpretationVideo consultations did not significantly improve the primary endpoint. However, compared with control, the intervention was associated with superior treatment satisfaction and a favourable effect on HbA

trial registrationClinicalTrials.gov NCT04612933

fundingThe study received funding from Knud and Edith Eriksens Mindefond. The Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital is supported by a core grant from the Oak Foundation.