成人 1 型糖尿病患者长达 2 年的自动化胰岛素输注：一项真实世界、多中心研究。

Automated insulin delivery among adults with type 1 diabetes for up to 2 years: a real-world, multicentre study.

机构信息

Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.

Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.

出版信息

Intern Med J. 2024 Jan;54(1):121-128. doi: 10.1111/imj.16143. Epub 2023 Jun 16.

DOI:10.1111/imj.16143

PMID:37255209

Abstract

BACKGROUND AND AIMS

Automated insulin delivery (AID) improves glycaemia among people with type 1 diabetes in clinical trials and overseas real-world studies. Whether improvements are sustained beyond 12 months in the real world, and whether they occur in the Australian context, has not yet been established. We aimed to observe, up to 2 years, the effectiveness of initiating first-generation AID for type 1 diabetes management.

METHODS

Retrospective, real-world, observational study using medical records, conducted across five sites in Australia. Adults with type 1 diabetes, who had AID initiated between February 2019 and December 2021, were observed for 6-24 months after initiation (until June 2022). Outcomes examined included glucose metrics assessed by glycated haemoglobin (HbA ) and continuous glucose monitoring (CGM), safety and therapy continuation.

RESULTS

Ninety-four adults were studied (median age 39 years (interquartile range, IQR: 31-51); pre-initiation HbA 7.8% (7.2-8.6)). After AID initiation, HbA decreased by mean 0.5 percentage points (95% confidence interval (CI): -0.7 to -0.2) at 3 months (P < 0.001); CGM time in range 3.9-10.0 mmol/L increased by 11 percentage points (9-14) at 1 month (P < 0.001); these improvements were maintained up to 24 months (all P < 0.02). Median CGM time below 3.9 mmol/L was <1.5% pre- and post-AID initiation. The subgroup with pre-initiation HbA above 8.5% had the greatest HbA improvement (-1.4 percentage points (-1.8 to -1.1) at 3 months). Twelve individuals (13%) discontinued AID, predominantly citing difficulties with CGM. During the 150 person-years observed, four diabetes-related emergencies were documented: three severe hypoglycaemic events and one hyperglycaemic event without ketoacidosis.

CONCLUSIONS

Early glucose improvements were observed after real-world AID initiation, sustained up to 2 years, without excess adverse events. The greatest benefits were observed among individuals with highest glycaemia before initiation. Future-generation systems with increased user-friendliness may enhance therapy continuation.

摘要

背景与目的

在临床试验和海外真实世界研究中，自动胰岛素输送（AID）改善了 1 型糖尿病患者的血糖水平。在真实世界中，这种改善是否能持续 12 个月以上，以及是否能在澳大利亚的环境中发生，尚未得到证实。我们的目的是观察第一代 AID 在 1 型糖尿病管理中的有效性，最长可达 2 年。

方法

这是一项在澳大利亚五个地点进行的回顾性、真实世界、观察性研究，使用病历资料。在 2019 年 2 月至 2021 年 12 月期间启动 AID 的 1 型糖尿病成年人，在启动后 6-24 个月（直至 2022 年 6 月）进行观察。评估的结果包括糖化血红蛋白（HbA ）和连续血糖监测（CGM）评估的葡萄糖指标、安全性和治疗的持续时间。

结果

共有 94 名成年人参与了研究（中位年龄 39 岁（四分位距，IQR：31-51）；启动前 HbA 为 7.8%（7.2-8.6%））。在 AID 启动后，HbA 在 3 个月时平均下降 0.5 个百分点（95%置信区间（CI）：-0.7 至 -0.2）（P < 0.001）；CGM 时间在 3.9-10.0 mmol/L 范围内增加了 11 个百分点（9-14），在 1 个月时（P < 0.001）；这些改善在 24 个月时仍然保持（均 P < 0.02）。在 AID 启动前和启动后，CGM 时间低于 3.9 mmol/L 的中位数均<1.5%。HbA 高于 8.5%的亚组的 HbA 改善最大（3 个月时下降 1.4 个百分点（-1.8 至 -1.1））。12 名患者（13%）停止了 AID，主要是因为 CGM 困难。在观察的 150 人年中，记录了 4 例与糖尿病相关的紧急情况：3 例严重低血糖事件和 1 例无酮症酸中毒的高血糖事件。