Despite the increasing adoption of insulin pumps and continuous glucose monitoring devices, most people with type 1 diabetes do not achieve their glycemic goals¹. This could be related to a lack of expertise or inadequate time for clinicians to analyze complex sensor-augmented pump data. We tested whether frequent insulin dose adjustments guided by an automated artificial intelligence-based decision support system (AI-DSS) is as effective and safe as those guided by physicians in controlling glucose levels. ADVICE4U was a six-month, multicenter, multinational, parallel, randomized controlled, non-inferiority trial in 108 participants with type 1 diabetes, aged 10–21 years and using insulin pump therapy (ClinicalTrials.gov no. NCT03003806). Participants were randomized 1:1 to receive remote insulin dose adjustment every three weeks guided by either an AI-DSS, (AI-DSS arm, n = 54) or by physicians (physician arm, n = 54). The results for the primary efficacy measure—the percentage of time spent within the target glucose range (70–180 mg dl⁻¹ (3.9–10.0 mmol l⁻¹))—in the AI-DSS arm were statistically non-inferior to those in the physician arm (50.2 ± 11.1% versus 51.6 ± 11.3%, respectively, P < 1 × 10⁻⁷). The percentage of readings below 54 mg dl⁻¹ (<3.0 mmol l⁻¹) within the AI-DSS arm was statistically non-inferior to that in the physician arm (1.3 ± 1.4% versus 1.0 ± 0.9%, respectively, P < 0.0001). Three severe adverse events related to diabetes (two severe hypoglycemia, one diabetic ketoacidosis) were reported in the physician arm and none in the AI-DSS arm. In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers.

尽管越来越多地采用胰岛素泵和连续葡萄糖监测设备，但大多数1型糖尿病患者仍未达到其血糖目标¹。这可能与缺乏专业知识或临床医生没有足够的时间来分析复杂的传感器增强的泵数据有关。我们测试了基于自动人工智能的决策支持系统（AI-DSS）指导的频繁胰岛素剂量调整是否与医生指导的控制血糖水平一样有效和安全。ADVICE4U是一项为期六个月，多中心，跨国，平行，随机对照，非劣效性的试验，研究对象为108位年龄在10-21岁之间的1型糖尿病参与者，并使用胰岛素泵治疗（ClinicalTrials.gov编号NCT03003806）。参加者按照AI-DSS（AI-DSS组，n  = 54）或医师（内科组，n）的指导，每三周1：1随机接受远程胰岛素剂量调整 = 54）。AI-DSS组中主要功效指标的结果（在目标葡萄糖范围内花费的时间百分比（70-180 mg dl ^-1（3.9-10.0 mmol l ^-1）））在统计学上不逊于那些在医师手臂中（分别为50.2±11.1％和51.6±11.3％，P  <1×10 ^-7）。AI-DSS组中读数低于54 mg dl ^-1（<3.0 mmol l ^-1）的百分比在统计学上不逊于医师组（分别为1.3±1.4％和1.0±0.9％，P <0.0001）。在医师组中报告了与糖尿病相关的三个严重不良事件（两个严重的低血糖，一个糖尿病性酮症酸中毒），而在AI-DSS分支中均未报告。总之，使用自动决策支持工具来优化胰岛素泵设置并不逊色于来自专业糖尿病学研究中心的医生提供的强化胰岛素滴定。