1型糖尿病中开放源代码的自动胰岛素输送（AID）系统- androidaps到市售的AID系统的切换：CODIAC研究的扩展

IF 6.3 2区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes technology & therapeutics Pub Date : 2025-09-10 DOI:10.1177/15209156251376013

Quoc Dat Do, Lucie Radovnická, Aneta Hásková, Judita Konečná, Eva Horová, George Grunberger, Martin Prázný, Christopher G Parkin, Milan Flekač, Jan Šoupal

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引用次数: 0

摘要

目的：本研究旨在探讨在一项新的扩展随访研究中，开放源代码的自动胰岛素递送（OS-AID）系统AndroidAPS （AAPS）与市售的胰岛素递送系统Control-IQ （CIQ）和MiniMed 780G （780G）之间的切换。研究设计和方法：在这项前瞻性开放标签单臂临床试验中，41名自愿使用AAPS的成人1型糖尿病患者（年龄35±11岁，糖化血红蛋白[HbA1c] 6.4±2.8%[46±6.8 mmol/mol]）共进入三个研究阶段。在第一阶段，参与者继续使用AAPS 3个月。在第二个为期3个月的研究阶段，所有参与者开始使用CIQ （n = 25）或780G （n = 16）。最后，在最后3个月的阶段，参与者被切换回AAPS。将市售AID系统的处理结果与两个AAPS阶段进行比较。结果：市售系统在TIR（84.2±7.6比85±6.9%,P = 0.31）和HbA1c（6.4±3比6.3±2.7%[46±8.8比45.7±6.2 mmol/mol], P = 0.68）方面与AAPS相当。相比之下，AAPS患者的近程时间（TITR）明显高于前者（66.38±11.84∶63.4±11.77,P = 0.035）。但在低血糖期的时间P < 0.001)。这些结果在切换回AAPS后是一致的。结论：不同混合闭环系统（androidaps和control - iq）在成人1型糖尿病患者中的比较研究是唯一一项调查OS和市售AID系统之间切换的前瞻性研究。从AAPS到商用系统的转换与TIR的变化无关。然而，使用AAPS与较高的TITR相关，但也与较高的低血糖风险相关。

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Switch of Open-Source Automated Insulin Delivery (AID) System-AndroidAPS to Commercially Available AID Systems in Type 1 Diabetes: The Extension of the CODIAC Study.

Objective: This study was designed to investigate the switch between the open-source automated insulin delivery (OS-AID) system AndroidAPS (AAPS) and commercially available AID systems Control-IQ (CIQ) and MiniMed 780G (780G) conducted in a new extended follow-up study. Research Design and Methods: In this prospective open-label single-arm clinical trial, 41 adults with type 1 diabetes (age 35 ± 11 years, glycated hemoglobin [HbA1c] 6.4 ± 2.8% [46 ± 6.8 mmol/mol]) who have voluntarily used AAPS entered a total of three study phases. In the first phase, participants continued with AAPS for 3 months. In the second 3-month study phase, all participants initiated CIQ (n = 25) or 780G (n = 16). Finally, participants were switched back to the AAPS for the last 3 months phase. Results of the treatment with commercially available AID systems were compared with both AAPS phases. Results: Commercially available systems were comparable to AAPS in achieving time in range (TIR) (84.2 ± 7.6 vs. 85 ± 6.9%; P = 0.31) and in HbA1c (6.4 ± 3 vs. 6.3 ± 2.7% [46 ± 8.8 vs. 45.7 ± 6.2 mmol/mol]; P = 0.68). In contrast, time in tight range (TITR) was significantly higher in AAPS (66.38 ± 11.84 vs. 63.4 ± 11.77, P = 0.035). However, the time in hypoglycemia <70 mg/dL [<3.9 mmol/L] was significantly lower with commercially available AID systems (2.2 ± 1.2 vs. 3.8 ± 1.9%; P < 0.001). These results were consistent after switching back to AAPS. Conclusion: The extension of the Comparison of Different Hybrid Closed-Loop Systems-AndroidAPS and Control-IQ-in adults with Type 1 Diabetes study is the only prospective study to investigate switching between OS and commercially available AID systems. The switch from AAPS to commercially available systems was not associated with a change in TIR. However, the use of AAPS was associated with a higher TITR, but also with a higher risk of hypoglycemia.

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来源期刊

Diabetes technology & therapeutics 医学-内分泌学与代谢

CiteScore

10.60

自引率

14.80%

发文量

145

审稿时长

3-8 weeks

期刊介绍： Diabetes Technology & Therapeutics is the only peer-reviewed journal providing healthcare professionals with information on new devices, drugs, drug delivery systems, and software for managing patients with diabetes. This leading international journal delivers practical information and comprehensive coverage of cutting-edge technologies and therapeutics in the field, and each issue highlights new pharmacological and device developments to optimize patient care.