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

Methods

We carried out a 52 week, open label, randomised, controlled superiority trial including adult type 1 diabetes patients treated with insulin pumps.

我们进行了一项为期52周的开放标签、随机、对照的优效试验，包括使用胰岛素泵治疗的成年1型糖尿病患者。

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.

参与者从南日德兰医院招募，为成年患者，被诊断为1型糖尿病，并且至少使用胰岛素泵6个月。

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.

参与者被随机分配到视频咨询（干预组）或面对面咨询（对照组），使用计算机生成的分块随机序列进行1:1分配，按传感器类型（连续血糖监测和闪光血糖监测）进行分层。由于这是一项'开放标签'试验，因此在随机分配后，提供治疗的医疗专业人员和参与者均未对分配进行盲法处理。

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.

主要结果指标是第51周至第52周目标范围内时间（TiR，血糖水平3.9-10.0 mmol/l）的百分比，通过连续血糖监测测量。

Continuous endpoints were analysed using ANCOVA, with randomised treatment and stratification groups as fixed effects and the baseline value as a covariate.

连续终点使用协方差分析（ANCOVA）进行分析，其中随机治疗和分层组作为固定效应，基线值作为协变量。

Missing data in the intention-to-treat(ITT) population were addressed using multiple imputation.

在意向性治疗(ITT)人群中，使用多重插补法处理了缺失数据。

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.

在随机分配的76名参与者中（ITT人群，每组38人，中位年龄49岁，女性占51%），干预组有32名参与者完成研究，对照组有31名参与者完成研究。

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).

在1年时，视频组的平均治疗反应(TiR)为64.3%，对照组为63.5%，两者之间的差异在临床上无显著性，差异为0.8个百分点（95%置信区间-5.3, 6.9; p=0.25）。

For secondary outcomes, the video group was superior in terms of treatment satisfaction and reduction in HbA1c.

对于次要结果，视频组在治疗满意度和降低HbA1c方面优于对照组。

However, the video group experienced an inferior impact on quality of life.

然而，视频组在生活质量方面受到了较差的影响。

conclusions/interpretation

Video consultations did not significantly improve the primary endpoint.

视频咨询并未显著改善主要终点。

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.

然而，与对照组相比，干预措施与更高的治疗满意度相关，并对糖化血红蛋白（HbA1c）产生了有利影响，尽管对生活质量的影响较差。

trial_registration

ClinicalTrials.gov NCT04612933 FUNDING: The study received funding from Knud and Edith Eriksens Mindefond.

ClinicalTrials.gov NCT04612933 资助：该研究获得了Knud和Edith Eriksens Mindefond的资助。

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.

帕克研究所生物统计学与循证研究部门，位于Bispebjerg和Frederiksberg医院，由橡树基金会的核心资助支持。