Mixed Methods Randomized Controlled Trial Comparing Quality of Life for Pregnant Women With Type 1 Diabetes Using Hybrid Closed-Loop to Sensor-Augmented Pump Therapy

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Endocrine Practice Pub Date : 2025-04-01 DOI:10.1016/j.eprac.2025.01.005

Elizabeth O. Buschur MD, FACE , Julia Reedy MA , Cari Berget RN, MPH, CDCES , Juliana G. Barnard MA , Rachel Garcetti PA-C, MS , Emily Nease MS, CDCES, RDN , Anna Bartholomew MPH, BSN, RN, CCRP , Carly Johnson BS , Kimberly A. Driscoll PhD , Kathleen M. Dungan MD, MPH , Janet K. Snell-Bergeon PhD , Laura L. Pyle PhD , Sarit Polsky MD, MPH

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引用次数: 0

Abstract

Objective

Type 1 diabetes in pregnancy is challenging. This study explores how assisted hybrid closed-loop therapy (HCL) versus sensor-augmented pump therapy (SAPT) impacts quality of life in pregnancy.

Methods

We interviewed 22 of 24 participants randomized to HCL or SAPT in the Pregnancy Intervention with a Closed-Loop System study. Participants completed questionnaires about hypoglycemia fear and device satisfaction and trust.

Results

Quality of life was similar among women with type 1 diabetes using HCL (n = 12) and SAPT (n = 12) throughout pregnancy and early postpartum. Hypoglycemia fear was not statistically different between groups but improved in the HCL group in the second trimester versus baseline. Glucose monitoring satisfaction and trust increased during pregnancy in the HCL group but decreased in the SAPT group. Women trusted their mode of insulin delivery despite stress and frustration with fluctuating glucose and risks of hyperglycemia to their fetuses. Women who preferred less involvement with their management preferred HCL, whereas those desiring more involvement preferred SAPT.

Conclusion

These similarities demonstrate that open communication is needed between provider and patient to determine perceived benefits versus burdens of HCL use in pregnancy, especially in the United States where available HCL systems lack pregnancy-specific algorithms and Food and Drug Administration approval for pregnancy use.

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混合方法RCT比较混合闭环（HCL）和传感器增强泵治疗（SAPT）对1型糖尿病孕妇生活质量的影响。

目的：妊娠期1型糖尿病（T1D）具有挑战性。本研究探讨了辅助混合闭环（HCL）治疗与传感器增强泵治疗（SAPT）对妊娠期生活质量（QoL）的影响。方法：我们采访了24名参与者中的22名，随机分配到HCL治疗或SAPT妊娠干预与闭环系统研究。参与者完成了关于低血糖恐惧、设备满意度和信任度的问卷调查。结果：T1D患者在整个妊娠期和产后早期使用HCL （n=12）和SAPT （n=12）的生活质量相似。低血糖恐惧在两组之间没有统计学差异，但在妊娠中期与基线相比，HCL组有所改善。妊娠期HCL组血糖监测满意度和信任度增加，SAPT组降低。尽管血糖波动和胎儿高血糖的风险给她们带来了压力和挫折，但妇女仍然信任她们的胰岛素输送模式。希望较少参与管理的女性首选HCL，而希望更多参与管理的女性首选SAPT。结论：这些相似之处表明，提供者和患者之间需要进行开放的沟通，以确定妊娠期使用HCL的预期收益和负担，特别是在美国，现有的HCL系统缺乏妊娠特异性算法和FDA批准的妊娠使用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Endocrine Practice ENDOCRINOLOGY & METABOLISM-

CiteScore

7.60

自引率

2.40%

发文量

546

审稿时长

41 days

期刊介绍： Endocrine Practice (ISSN: 1530-891X), a peer-reviewed journal published twelve times a year, is the official journal of the American Association of Clinical Endocrinologists (AACE). The primary mission of Endocrine Practice is to enhance the health care of patients with endocrine diseases through continuing education of practicing endocrinologists.