Aims/hypothesis <p>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.</p> Methods <p>We 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.</p> Results <p>Of 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; <i>p</i>=0.25). For secondary outcomes, the video group was superior in terms of treatment satisfaction and reduction in HbA<sub>1c</sub>. However, the video group experienced an inferior impact on quality of life.</p> Conclusions/interpretation <p>Video 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<sub>1c</sub>, albeit with an inferior impact on quality of life.</p> Trial registration <p>ClinicalTrials.gov NCT04612933</p> Funding <p>The 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.</p> Graphical Abstract <p></p>

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

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

  • Anders N. Ø. Schultz,
  • Robin Christensen,
  • Georg Bollig,
  • Kristian Kidholm,
  • Frans Brandt

摘要

Aims/hypothesis

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.

Methods

We 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.

Results

Of 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/interpretation

Video 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 registration

ClinicalTrials.gov NCT04612933

Funding

The 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