Katrien Benhalima, Johan Jendle, Kaat Beunen, Lene Ringholm
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Currently, the CamAPS<sup>®</sup> FX is the only AID approved for use in pregnancy. A recent randomized controlled trial (RCT) with CamAPS<sup>®</sup> FX demonstrated a 10% increase in time in range in a pregnant population with T1D and a baseline glycated hemoglobin (HbA1c) ≥ 48 mmol/mol (6.5%). Off-label use of AID not approved for pregnancy are currently also being evaluated in ongoing RCTs. More evidence is needed on the impact of AID on maternal and neonatal outcomes. We review the current evidence on the use of AID in pregnancy and provide an overview of the completed and ongoing RCTs evaluating AID in pregnancy. 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引用次数: 0
摘要
自动胰岛素输送(AID)系统通过与连续血糖监测(CGM)和胰岛素泵集成的预测算法模拟人工胰腺,从而提供自动胰岛素输送。除妊娠外,AID 已使 1 型糖尿病(T1D)患者的管理模式发生转变,从而改善了血糖控制,降低了低血糖风险,提高了生活质量。随着 AID 在临床实践中的使用越来越多,育龄妇女在使用 AID 期间怀孕的人数预计也会增加。与妊娠期外相比,妊娠期的血糖目标值要求更低,而且在妊娠期需要频繁调整胰岛素剂量,这可能会影响 AID 在非妊娠 T1D 患者中使用算法时的有效性和安全性。目前,CamAPS® FX 是唯一获准在孕期使用的 AID。最近一项使用 CamAPS® FX 的随机对照试验 (RCT) 表明,在患有 T1D 且基线糖化血红蛋白 (HbA1c) ≥ 48 mmol/mol (6.5%) 的妊娠人群中,在量程范围内的时间延长了 10%。目前正在进行的 RCT 研究也在评估未获批准用于妊娠的 AID 的标签外使用情况。关于 AID 对孕产妇和新生儿预后的影响,还需要更多的证据。我们回顾了目前有关妊娠期使用 AID 的证据,并概述了已完成和正在进行的评估妊娠期 AID 的 RCT。此外,我们还讨论了目前在孕期使用 AID 的优势和挑战以及未来的研究方向。
Automated Insulin Delivery for Pregnant Women With Type 1 Diabetes: Where Do We Stand?
Automated insulin delivery (AID) systems mimic an artificial pancreas via a predictive algorithm integrated with continuous glucose monitoring (CGM) and an insulin pump, thereby providing AID. Outside of pregnancy, AID has led to a paradigm shift in the management of people with type 1 diabetes (T1D), leading to improvements in glycemic control with lower risk for hypoglycemia and improved quality of life. As the use of AID in clinical practice is increasing, the number of women of reproductive age becoming pregnant while using AID is also expected to increase. The requirement for lower glucose targets than outside of pregnancy and for frequent adjustments of insulin doses during pregnancy may impact the effectiveness and safety of AID when using algorithms for non-pregnant populations with T1D. Currently, the CamAPS® FX is the only AID approved for use in pregnancy. A recent randomized controlled trial (RCT) with CamAPS® FX demonstrated a 10% increase in time in range in a pregnant population with T1D and a baseline glycated hemoglobin (HbA1c) ≥ 48 mmol/mol (6.5%). Off-label use of AID not approved for pregnancy are currently also being evaluated in ongoing RCTs. More evidence is needed on the impact of AID on maternal and neonatal outcomes. We review the current evidence on the use of AID in pregnancy and provide an overview of the completed and ongoing RCTs evaluating AID in pregnancy. In addition, we discuss the advantages and challenges of the use of current AID in pregnancy and future directions for research.
期刊介绍:
The Journal of Diabetes Science and Technology (JDST) is a bi-monthly, peer-reviewed scientific journal published by the Diabetes Technology Society. JDST covers scientific and clinical aspects of diabetes technology including glucose monitoring, insulin and metabolic peptide delivery, the artificial pancreas, digital health, precision medicine, social media, cybersecurity, software for modeling, physiologic monitoring, technology for managing obesity, and diagnostic tests of glycation. The journal also covers the development and use of mobile applications and wireless communication, as well as bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes.