Effectiveness of video consultations in type 1 diabetes patients treated with insulin pumps in the outpatient clinic: a randomised controlled trial
摘要
The 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 HbA1c. However, the video group experienced an inferior impact on quality of life.
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 HbA1c, albeit with an inferior impact on quality of life.
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.
Graphical Abstract