Hybrid closed-loop glucose control compared with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study.
Hybrid closed-loop glucose control compared with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study.
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DOI：
10.1016/s2666-7568(22)00005-8
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发表时间：
2022-03
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通讯作者：
Hovorka R
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作者：
Boughton CK;Hartnell S;Thabit H;Mubita WM;Draxlbauer K;Poettler T;Wilinska ME;Hood KK;Mader JK;Narendran P;Leelarathna L;Evans ML;Hovorka R
患有1型糖尿病的老年人有明显的特点，这使得优化血糖控制具有挑战性。我们试图验证我们的假设，即在老年1型糖尿病患者中，混合闭环血糖控制比传感器增强泵(SAP)治疗更安全和更有效。在一项开放标签、多中心、多国(英国和奥地利)、随机、交叉研究中，60岁及以上使用胰岛素泵疗法的1型糖尿病患者经历了两个为期16周的时间段，按随机顺序比较混合闭环(CamAPS FX、CamDiab，英国剑桥)和SAP疗法。通过中心随机化软件对两个治疗序列中的一个进行区组随机化，并按中心进行分层。主要终点是时间传感器血糖在3.9~10.0 mmol/L的目标范围内，对主要终点和不良事件的分析采用意向处理。这项研究已经完成，并在ClinicalTrials.gov NCT04025762上注册。共有38名参与者参加。一名参与者在磨合期间因研究泵输液器的困难而退出。37名参与者(年龄中位数68[63-70]岁，平均[SD]基线糖化血红蛋白[HbA1c]；7.4%[0.9%]；57[10]mmol/mol)在2019年9月4日至2020年10月2日期间被随机分配。闭合组血糖在3.9~10.0 mmol/L之间的时间比例显著高于SAP组(79.9%[SD7.9vs71.4%[13.2]，差异8.6个百分点[95%CI6.3to11.0]；p<；0.0001)。SAP期间发生了两次严重低血糖事件。有两个非治疗相关的严重不良事件：SAP期间因新冠肺炎相关的肺栓塞导致心脏骤停导致死亡，以及一名在磨合期肾上腺功能不全的参与者因新冠肺炎而住院。在长期患有1型糖尿病的老年人中，混合闭环胰岛素注射是安全的，并实现了比SAP疗法更好的血糖控制。重要的是，在这些有严重低血糖危险因素的人群中，这是在没有增加低血糖风险的情况下实现的。这表明，对于患有1型糖尿病的老年人来说，混合闭环治疗是一种具有重要临床意义的治疗选择。
Older adults with type 1 diabetes have distinct characteristics that can make optimising glycaemic control challenging. We sought to test our hypothesis that hybrid closed-loop glucose control is safe and more effective than sensor-augmented pump (SAP) therapy in older adults with type 1 diabetes. In an open-label, multicentre, multinational (UK and Austria), randomised, crossover study, adults aged 60 years and older with type 1 diabetes using insulin pump therapy underwent two 16-week periods comparing hybrid closed-loop (CamAPS FX, CamDiab, Cambridge, UK) and SAP therapy in random order. Block randomisation by means of central randomisation software to one of two treatment sequences was stratified by centre. The primary endpoint was the proportion of time sensor glucose was in target range between 3·9 and 10·0 mmol/L. Analysis for the primary endpoint and adverse events was by intention-to-treat. The study has completed and is registered at ClinicalTrials.gov NCT04025762. 38 participants were enrolled. One participant withdrew during run-in because of difficulties with the study pump infusion sets. 37 participants (median [IQR] age 68 [63–70] years, mean [SD] baseline glycated haemoglobin [HbA1c]; 7·4% [0·9%]; 57 [10] mmol/mol) were randomly assigned between Sept 4, 2019, and Oct 2, 2020. The proportion of time with glucose between 3·9 and 10·0 mmol/L was significantly higher in the closed-loop group compared to the SAP group (79·9% [SD 7·9] vs 71·4% [13·2], difference 8·6 percentage points [95% CI 6·3 to 11·0]; p<0·0001). Two severe hypoglycaemia events occurred during the SAP period. There were two non-treatment related serious adverse events: cardiac arrest from pulmonary embolism associated with COVID-19 during the SAP period resulting in death, and a hospital presentation for parenteral hydrocortisone because of COVID-19 in a participant with adrenal insufficiency during the run-in period. Hybrid closed-loop insulin delivery is safe and achieves superior glycaemic control to SAP therapy in older adults with long duration of type 1 diabetes. Importantly this was achieved without increasing the risk of hypoglycaemia in this population with risk factors for severe hypoglycaemia. This suggests that hybrid closed-loop therapy is a clinically important treatment option for older adults with type 1 diabetes.