Effects of atmospheric pressure change during flight on insulin pump delivery and glycaemic control of pilots with insulin-treated diabetes: an in vitro simulation and a retrospective observational real-world study.

IF 8.4 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM
Gillian L Garden, Ka Siu Fan, Megan Paterson, Fariba Shojaee-Moradie, Monique Borg Inguanez, Antonios Manoli, Victoria Edwards, Vivienne Lee, Brian M Frier, Ewan J Hutchison, Declan Maher, Chantal Mathieu, Stuart J Mitchell, Simon R Heller, Graham A Roberts, Kenneth M Shaw, Gerd Koehler, Julia K Mader, Bruce R King, David L Russell-Jones
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Abstract

Aims/hypothesis: Glycaemic control and clinical outcomes in diabetes are improved by continuous subcutaneous insulin infusion (CSII). Atmospheric pressure changes during flights may affect insulin delivery from pumps and cause unintended metabolic consequences, including hypoglycaemia, in people with type 1 diabetes. The present report evaluates both hypobaric flight simulation and real-world data in pilots using insulin pumps while flying.

Methods: In the flight simulation part of this study, an in vitro study of insulin pumps was conducted in a hypobaric chamber, de-pressurised to 550 mmHg to mimic the atmospheric pressure changes in airliner cabins during commercial flights. Insulin delivery rates and bubble formation were recorded for standard flight protocol. Insulin infusion sets, without pumps, were tested in a simulated rapid decompression scenario. The real-world observational study was a 7.5-year retrospective cohort study in which pre- and in-flight self-monitored blood glucose (SMBG) values were monitored in pilots with insulin-treated diabetes. Commercial and private pilots granted a medical certificate to fly within the European Union Aviation Safety Agency approved protocol and receiving insulin either by pump or multiple daily injections (MDI) were included.

Results: In the flight simulation study, full cartridges over-delivered 0.60 U of insulin during a 20 min ascent and under-delivered by 0.51 U during descent compared with ground-level performance. During emergency rapid decompression, 5.6 U of excess insulin was delivered. In the real-world study, seven pilots using CSII recorded 4656 SMBG values during 2345 h of flying across 1081 flights. Only 33 (0.7%) values were outside an acceptable safe range (5.0-15.0 mmol/l [90-270 mg/dl]). No clinically significant fall in the median SMBG concentration was observed after aircraft ascent and no in-flight SMBG values were within the hypoglycaemic range (<4.0 mmol/l [<72 mg/dl]). Compared with pilots receiving MDI therapy, pilots using CSII recorded more SMBG values within the acceptable range (99.3% vs 97.5%), fewer values in the low red range (0.02% vs 0.1%), fewer in-flight out-of-range values (0.2% vs 1.3%) and maintained stricter glycaemic control during flight.

Conclusions/interpretation: Ambient pressure reduction during simulated flights results in bubble formation and expansion within insulin cartridges. This causes unintended delivery of small insulin doses independent of pre-determined delivery rates and represents the maximum amount of insulin that could be delivered and retracted. However, in vivo, pilots using CSII in-flight did not experience a fall in blood glucose or episodes of hypoglycaemia during these atmospheric pressure changes and the use of insulin pumps can be endorsed in view of their clinical benefits.

Abstract Image

飞行过程中大气压力变化对胰岛素泵输送和胰岛素治疗糖尿病飞行员血糖控制的影响:体外模拟和回顾性实际观察研究。
目的/假设:持续皮下注射胰岛素(CSII)可改善糖尿病患者的血糖控制和临床疗效。飞行过程中的气压变化可能会影响胰岛素泵的胰岛素输送,并对 1 型糖尿病患者造成意想不到的代谢后果,包括低血糖。本报告评估了飞行员在飞行时使用胰岛素泵的低压模拟飞行和实际数据:在本研究的飞行模拟部分,在低压舱中对胰岛素泵进行了体外研究,低压舱减压至 550 mmHg,以模拟商业航班客舱中的大气压力变化。根据标准飞行协议记录了胰岛素输送率和气泡形成情况。在模拟快速减压情况下测试了不带泵的胰岛素输注装置。真实世界观察研究是一项为期 7.5 年的回顾性队列研究,对接受过胰岛素治疗的糖尿病飞行员进行飞行前和飞行中自我监测血糖 (SMBG) 值的监测。研究对象包括获得欧盟航空安全局批准的飞行医疗证书、通过泵或每日多次注射(MDI)方式接受胰岛素治疗的商业飞行员和私人飞行员:在模拟飞行研究中,与地面飞行相比,满瓶胰岛素在 20 分钟的上升过程中多输送了 0.60 U,在下降过程中少输送了 0.51 U。在紧急快速减压期间,胰岛素超量输送了 5.6 U。在真实世界研究中,7 名使用 CSII 的飞行员在 1081 次飞行的 2345 小时内记录了 4656 个 SMBG 值。只有 33 个值(0.7%)超出了可接受的安全范围(5.0-15.0 mmol/l [90-270 mg/dl])。飞机上升后,SMBG 中位浓度没有出现临床意义上的明显下降,飞行中的 SMBG 值也没有超出低血糖范围(结论/解释:模拟飞行过程中环境压力的降低导致胰岛素盒内气泡的形成和膨胀。这导致了小剂量胰岛素的意外输送,而不受预定输送率的影响,并代表了可输送和缩回的最大胰岛素量。不过,在实际飞行中,使用 CSII 的飞行员在这些气压变化期间并没有出现血糖下降或低血糖的情况,鉴于其临床益处,胰岛素泵的使用可以得到认可。
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来源期刊
Diabetologia
Diabetologia 医学-内分泌学与代谢
CiteScore
18.10
自引率
2.40%
发文量
193
审稿时长
1 months
期刊介绍: Diabetologia, the authoritative journal dedicated to diabetes research, holds high visibility through society membership, libraries, and social media. As the official journal of the European Association for the Study of Diabetes, it is ranked in the top quartile of the 2019 JCR Impact Factors in the Endocrinology & Metabolism category. The journal boasts dedicated and expert editorial teams committed to supporting authors throughout the peer review process.
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