使用自制人工胰腺系统的混合闭环在成年 1 型糖尿病患者中的应用。
Hybrid Closed Loop Using a Do-It-Yourself Artificial Pancreas System in Adults With Type 1 Diabetes.
机构信息
Department of Diabetes Clinical Research, Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.
Department of Endocrinology and Diabetes, Eastern Health, Box Hill, VIC, Australia.
出版信息
J Diabetes Sci Technol. 2024 Jul;18(4):889-896. doi: 10.1177/19322968231153882. Epub 2023 Feb 14.
OBJECTIVE
There is increasing use of open-source artificial pancreas systems (APS) in the management of Type 1 diabetes. Our aim was to assess the safety and efficacy of the automated insulin delivery system AndroidAPS (AAPS), compared with stand-alone pump therapy in people with type 1 diabetes. The primary outcome was the difference in the percentage of time in range (TIR, 70-180 mg/dL). Secondary aims included mean sensor glucose value and percent continuous glucose monitor (CGM) time below range (TBR, <70 mg/dL).
RESEARCH DESIGN AND METHODS
This open-label single-center randomized crossover study (ANZCTR, Australian New Zealand clinical trial registry, ANZCTR-ACTRN12620001191987) comprised 20 participants with type 1 diabetes on established pump therapy, assigned to either stand-alone insulin pump therapy or the open-source AAPS hybrid closed-loop system for four weeks, with crossover to the alternate arm for the following four weeks. The CGM outcome parameters were measured by seven-day CGM at baseline and the final week of each four-week study arm.
RESULTS
Twenty participants were recruited (60% women), aged 45.8 ± 15.9 years, with mean diabetes duration of 23.9 ± 13.2 years, baseline glycated hemoglobin (HbA1c) 7.5% ± 0.5% (58 ± 6 mmol/mol) and mean TIR 62.3% ± 12.9%. The change in TIR from baseline for AAPS compared with stand-alone pump therapy was 18.6% (11.4-25.9), ( < .001), TIR 76.6% ± 11.7%, 58.0% ± 15.6%, for AAPS and stand-alone pump, respectively. Time glucose <54 mg/dL was not increased (mean = -2.0%, = .191). No serious adverse events or episodes of severe hypoglycemia were recorded.
CONCLUSIONS
This clinical trial of the open-source AAPS hybrid closed-loop system performed in an at-home setting demonstrated comparable safety to stand-alone pump therapy. The glycemic outcomes of AAPS were superior with improved TIR, and there was no significant difference in TBR compared with stand-alone pump therapy.
目的
开源人工胰腺系统（APS）在 1 型糖尿病管理中的应用日益增多。本研究旨在评估与独立泵治疗相比，1 型糖尿病患者使用自动化胰岛素输送系统 AndroidAPS（AAPS）的安全性和疗效。主要结局指标为血糖控制在目标范围内（TIR，70-180mg/dL）的时间百分比差异。次要终点包括平均传感器血糖值和连续血糖监测仪（CGM）时间百分比低于目标范围（TBR，<70mg/dL）。
研究设计和方法
这是一项在家庭环境中进行的开放性单中心随机交叉研究（ANZCTR，澳大利亚新西兰临床试验注册处，ANZCTR-ACTRN12620001191987），共纳入 20 名接受胰岛素泵治疗的 1 型糖尿病患者，他们被随机分为接受独立胰岛素泵治疗或开源 AAPS 混合闭环系统治疗，为期 4 周，随后交叉至另一组治疗 4 周。在基线和每 4 周研究臂的最后一周，通过 7 天 CGM 测量 CGM 结局参数。
结果
共纳入 20 名参与者（60%为女性），年龄 45.8±15.9 岁，糖尿病病程平均为 23.9±13.2 年，基线糖化血红蛋白（HbA1c）为 7.5%±0.5%（58±6mmol/mol），TIR 为 62.3%±12.9%。与独立泵治疗相比，AAPS 的 TIR 变化为 18.6%（11.4-25.9）（<0.001），AAPS 和独立泵治疗的 TIR 分别为 76.6%±11.7%和 58.0%±15.6%。血糖<54mg/dL 的时间无明显增加（平均为-2.0%，=0.191）。未记录到严重不良事件或严重低血糖发作。
结论
本研究在家中环境下对开源 AAPS 混合闭环系统进行了临床试验，结果表明该系统与独立泵治疗相比具有相似的安全性。AAPS 的血糖控制效果更好，TIR 改善，与独立泵治疗相比，TBR 无显著差异。
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