Ka Siu Fan, Fariba Shojaee-Moradie, Antonios Manoli, Petra M Baumann, Gerd Koehler, Victoria Edwards, Vivienne Lee, Chantal Mathieu, Julia K Mader, David Russell-Jones
{"title":"低气压模拟实验评估闭环胰岛素输送系统在飞行相关气压变化中的安全性的可行性。","authors":"Ka Siu Fan, Fariba Shojaee-Moradie, Antonios Manoli, Petra M Baumann, Gerd Koehler, Victoria Edwards, Vivienne Lee, Chantal Mathieu, Julia K Mader, David Russell-Jones","doi":"10.1089/dia.2024.0380","DOIUrl":null,"url":null,"abstract":"<p><p>Hybrid closed-loop (HCL) systems remain underexplored within aviation, and as atmospheric pressure changes can independently affect insulin pumps and continuous glucose monitoring readings, this preliminary study assessed the feasibility of HCL safety evaluation, in both fasting and post-prandial states, by using hypobaric chamber to simulate flights. Participants with type 1 diabetes and on HCL were studied: Medtronic Guardian 4-Medtronic 780G-SmartGuard (<i>n</i> = 4), Dexcom G6-Omnipod DASH-Android APS (<i>n</i> = 1), and Dexcom G6-Ypsomed Pump-CamAPS (<i>n</i> = 1). Flight cabin pressures of 550 mmHg and 750 mmHg were simulated in a hypobaric chamber. Seven-hundred-50 glucose measurements were taken, with glucose levels demonstrating a stable decline to 4 mmol/L during fasting. To maintain a tight fasting and post-prandial glucose range across the different pressure settings, the HCL administered insulin as expected. While not demonstrating any apparent issues, repeating flight simulation protocol with other systems, examining longer flights, and undertaking larger, powered randomised controlled trials can confirm their safety in aviation.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7000,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The Feasibility of an Experimental Hypobaric Simulation to Evaluate the Safety of Closed-Loop Insulin Delivery Systems in Flight-Related Atmospheric Pressure Changes.\",\"authors\":\"Ka Siu Fan, Fariba Shojaee-Moradie, Antonios Manoli, Petra M Baumann, Gerd Koehler, Victoria Edwards, Vivienne Lee, Chantal Mathieu, Julia K Mader, David Russell-Jones\",\"doi\":\"10.1089/dia.2024.0380\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Hybrid closed-loop (HCL) systems remain underexplored within aviation, and as atmospheric pressure changes can independently affect insulin pumps and continuous glucose monitoring readings, this preliminary study assessed the feasibility of HCL safety evaluation, in both fasting and post-prandial states, by using hypobaric chamber to simulate flights. Participants with type 1 diabetes and on HCL were studied: Medtronic Guardian 4-Medtronic 780G-SmartGuard (<i>n</i> = 4), Dexcom G6-Omnipod DASH-Android APS (<i>n</i> = 1), and Dexcom G6-Ypsomed Pump-CamAPS (<i>n</i> = 1). Flight cabin pressures of 550 mmHg and 750 mmHg were simulated in a hypobaric chamber. Seven-hundred-50 glucose measurements were taken, with glucose levels demonstrating a stable decline to 4 mmol/L during fasting. To maintain a tight fasting and post-prandial glucose range across the different pressure settings, the HCL administered insulin as expected. While not demonstrating any apparent issues, repeating flight simulation protocol with other systems, examining longer flights, and undertaking larger, powered randomised controlled trials can confirm their safety in aviation.</p>\",\"PeriodicalId\":11159,\"journal\":{\"name\":\"Diabetes technology & therapeutics\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":5.7000,\"publicationDate\":\"2024-10-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diabetes technology & therapeutics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1089/dia.2024.0380\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes technology & therapeutics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1089/dia.2024.0380","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
The Feasibility of an Experimental Hypobaric Simulation to Evaluate the Safety of Closed-Loop Insulin Delivery Systems in Flight-Related Atmospheric Pressure Changes.
Hybrid closed-loop (HCL) systems remain underexplored within aviation, and as atmospheric pressure changes can independently affect insulin pumps and continuous glucose monitoring readings, this preliminary study assessed the feasibility of HCL safety evaluation, in both fasting and post-prandial states, by using hypobaric chamber to simulate flights. Participants with type 1 diabetes and on HCL were studied: Medtronic Guardian 4-Medtronic 780G-SmartGuard (n = 4), Dexcom G6-Omnipod DASH-Android APS (n = 1), and Dexcom G6-Ypsomed Pump-CamAPS (n = 1). Flight cabin pressures of 550 mmHg and 750 mmHg were simulated in a hypobaric chamber. Seven-hundred-50 glucose measurements were taken, with glucose levels demonstrating a stable decline to 4 mmol/L during fasting. To maintain a tight fasting and post-prandial glucose range across the different pressure settings, the HCL administered insulin as expected. While not demonstrating any apparent issues, repeating flight simulation protocol with other systems, examining longer flights, and undertaking larger, powered randomised controlled trials can confirm their safety in aviation.
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.