自动胰岛素输送对晚期慢性肾脏病糖尿病患者血糖管理的影响
主要终点为每阶段最后3周目标范围内时间百分比（3.9-10.0 mmol/l），AID较常规护理显著改善TIR（60% vs 73%，p<0.001），低血糖率无变化。
要点
- AID在晚期CKD糖尿病人群中可行且安全，无设备相关严重不良事件。
- AID较常规护理显著改善TIR（3.9-10.0 mmol/l），从60%升至73%。
- 低血糖发生率在AID与常规护理间无变化。
核心结论
- 在主要为衰弱前期的糖尿病合并晚期CKD患者中，AID可行、安全，且较常规护理提供更优的血糖管理。
研究设计与样本
- 前瞻性、开放标签、随机交叉试验，在澳大利亚五家三级医院和丹麦一家三级中心进行。
- 按1:1随机分配至AID后常规护理（实时CGM）或相反顺序，每阶段8周。
主要发现
- AID显著改善所有高血糖CGM指标。
- TIR（3.9-10.0 mmol/l）从常规护理结束时的60%（51%，66%）改善至AID结束时的73%（65%，78%）（p<0.001）。
- 低血糖率无变化；无设备相关严重不良事件；25%参与者在试验期间因与设备无关的医疗问题住院。
关键数值与推荐
- 主要终点为每治疗阶段最后3周TIR（3.9-10.0 mmol/l）百分比。
- 参与者中位（IQR）年龄60（55，69）岁，HbA1c 64（54，73）mmol/mol [8.0%（7.1%，8.8%）]，eGFR 30（18，37）ml/min per 1.73 m2。
- 33例非透析，4例腹膜透析，3例血液透析。
临床怎么用
- 对于糖尿病合并晚期CKD（含透析）患者，AID可作为改善血糖管理的可行选择。
- 应用AID时需关注非设备相关的住院风险。
局限性
- 研究期限较短（每阶段8周），结论需在更大人群和更长期限中验证。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
AIMS/HYPOTHESIS: Chronic kidney disease (CKD) complicates insulin dosing and increases glycaemic instability in diabetes. We aimed to compare feasibility, safety and efficacy of automated insulin delivery (AID) with usual care in people with diabetes and advanced CKD. METHODS: We conducted a prospective, open-label, randomised crossover trial at five tertiary hospitals in Australia and one tertiary centre in Denmark. Adults aged ≥18 years with type 1 diabetes or insulin-treated type 2 diabetes and advanced CKD (stage 3b or higher, including dialysis) were eligible. Participants were randomly assigned in a 1:1 sequence to receive either AID followed by usual care with real-time continuous glucose monitoring (CGM), or the reverse sequence, each for 8 weeks. Allocation was generated centrally using computerised randomisation. Due to the nature of the intervention, participants and clinicians were aware of treatment assignment. The primary outcome was percentage time in range (3.9-10.0 mmol/l) during the final 3 weeks of each treatment period. RESULTS: Forty participants (24 type 1 diabetes, 16 type 2 diabetes; median [IQR] age 60 [55, 69] years; HbA1c 64 [54, 73] mmol/mol [8.0% (7.1%, 8.8%)]; eGFR 30 [18, 37] ml/min per 1.73 m2) were enrolled: 33 not on dialysis, four on peritoneal dialysis and three on haemodialysis. AID significantly improved all hyperglycaemic CGM metrics compared with usual care. Time in range (3.9-10.0 mmol/l) improved from 60% (51%, 66%) at the end of usual care to 73% (65%, 78%) at the end of AID (p<0.001). Hypoglycaemia rates were unchanged. Participants were predominantly pre-frail at baseline and remained stable on-trial. No serious adverse events were attributed to the study devices. Nonetheless, 25% of participants experienced hospital admissions during the trial period for medical issues unrelated to device use. CONCLUSIONS/INTERPRETATION: AID is feasible and safe and compared with usual care provides superior glucose management in predominantly pre-frail people with diabetes complicated by advanced CKD. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12622000889752; ClinicalTrials.gov NCT06330194 FUNDING: This trial was funded by the Australian Centre for Advancing Diabetes Innovations (ACADI), St Vincent's Hospital Melbourne and Diabetes Australia.
引用
- Lu JC, Meyer-Olesen CL, Halim B, et al. The impact of automated insulin delivery on glucose management in people with diabetes and advanced chronic kidney disease. Diabetologia. 2026. PMID: 42108331. doi:10.1007/s00125-026-06732-3
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。