Talbo Meryem K, Katz Alexandra, Hill Lee, Peters Tricia M, Yale Jean-François, Brazeau Anne-Sophie
School of Human Nutrition, McGill University, 21111 Lakeshore Road, Ste-Anne-de-Bellevue, Québec H9X 3V9, Canada.
Faculté de Médecine, Université de Montréal, 2900 Edouard Montpetit Blvd, Montréal, Québec H3T 1J4, Canada.
EClinicalMedicine. 2023 Aug 4;62:102119. doi: 10.1016/j.eclinm.2023.102119. eCollection 2023 Aug.
Fear of hypoglycaemia (FOH) significantly disrupts the daily management of type 1 diabetes (T1D) and increases the risk of complications. Recent technological advances can improve glucose metrics and reduce hypoglycaemia frequency, yet their impact on FOH is unclear. This systematic review and meta-analysis (SRMA) aimed to synthesize the current literature to understand the impact of diabetes technologies on FOH in T1D.
In this SRMA, we searched PubMed, Medline, Scopus, and Web of Science from inception up to May 21st, 2023 for studies assessing the effect of using real-time or intermittently scanned continuous glucose monitors (rtCGM or isCGM); insulin pumps (CSII); and their combinations on FOH as the primary outcome, measured using the Hypoglycaemia Fear Survey (HFS; including total, worries [HFS-W], and behaviours [HFS-B] scores), in non-pregnant adults with T1D. Data was extracted by the first and second authors. Results were pooled using a random-effects model based on study design (RCT and non-RCT), with subgroup analysis based on the type of technology, reported change in hypoglycaemia frequency, and duration of use. Risk of bias was evaluated with Cochrane and Joanna Briggs Institute tools. This study is registered with PROSPERO, CRD42021253618.
A total of 51 studies (n = 8966) were included, 22 of which were RCTs. Studies on rtCGM and CSII reported lower FOH levels with ≥8 weeks of use. Studies on CSII and rtCGM combinations reported lower FOH levels after ≥13 weeks of automated insulin delivery (AID) use or 26 weeks of sensor-augmented pump (SAP) use. The meta-analysis showed an overall lower FOH with technologies, specifically for the HFS-W subscale. The RCT meta-analysis showed lower HFS-W scores with rtCGM use (standard mean difference [95%CI]: -0.14 [-0.23, -0.05], I = 0%) and AID (-0.17 [-0.33, -0.01], I = 0%). Results from non-RCT studies show that SAP users (-0.33 [-0.38, -0.27], I = 0%) and rtCGM users (-0.38 [-0.61, -0.14], I = 0%) had lower HFS-W.
We found consistent, yet small to moderate, effects supporting that diabetes technologies (specifically rtCGM, SAP, and AID) may reduce hypoglycaemia-related worries in adults with T1D. Current literature, however, has limitations including discrepancies in baseline characteristics and limited, mainly descriptive, statistical analysis. Thus, future studies should assess FOH as a primary outcome, use validated surveys, and appropriate statistical analysis to evaluate the clinical impacts of technology use beyond just glucose metrics.
Canadian Institutes of Health Research, Juvenile Diabetes Research Foundation Ltd.
低血糖恐惧（FOH）严重干扰1型糖尿病（T1D）的日常管理，并增加并发症风险。近期的技术进步可改善血糖指标并降低低血糖发生频率，但其对FOH的影响尚不清楚。本系统评价和荟萃分析（SRMA）旨在综合现有文献，以了解糖尿病技术对T1D患者FOH的影响。
在本SRMA中，我们检索了PubMed、Medline、Scopus和Web of Science数据库，检索时间从建库至2023年5月21日，以查找评估使用实时或间歇扫描式连续血糖监测仪（rtCGM或isCGM）、胰岛素泵（CSII）及其组合对FOH影响的研究，将其作为主要结局，采用低血糖恐惧量表（HFS，包括总分、担忧[HFS-W]和行为[HFS-B]得分）对非妊娠T1D成年患者进行测量。数据由第一作者和第二作者提取。根据研究设计（随机对照试验和非随机对照试验），使用随机效应模型汇总结果，并根据技术类型、报告的低血糖发生频率变化和使用时长进行亚组分析。使用Cochrane和乔安娜·布里格斯研究所工具评估偏倚风险。本研究已在国际前瞻性系统评价注册库（PROSPERO）注册，注册号为CRD42021253618。
共纳入51项研究（n = 8966），其中22项为随机对照试验。关于rtCGM和CSII的研究报告称，使用≥8周后FOH水平降低。关于CSII和rtCGM组合的研究报告称，在自动胰岛素给药（AID）使用≥13周或传感器增强泵（SAP）使用26周后FOH水平降低。荟萃分析显示，使用这些技术总体上FOH较低，特别是在HFS-W子量表方面。随机对照试验的荟萃分析显示，使用rtCGM（标准化均数差[95%置信区间]：-0.14[-0.23, -0.05]，I² = 0%）和AID（-0.17[-0.33, -0.01]，I² = 0%）时HFS-W得分较低。非随机对照试验的结果显示，SAP使用者（-0.33[-0.38, -0.27]，I² = 0%）和rtCGM使用者（-0.38[-0.61, -0.14]，I² = 0%）的HFS-W较低。
我们发现一致但小到中等程度的效应，支持糖尿病技术（特别是rtCGM、SAP和AID）可能会减少T1D成年患者与低血糖相关的担忧。然而，当前文献存在局限性，包括基线特征存在差异以及有限的、主要为描述性的统计分析。因此，未来的研究应将FOH作为主要结局进行评估，使用经过验证的量表，并进行适当的统计分析，以评估技术使用除血糖指标之外的临床影响。
加拿大卫生研究院、青少年糖尿病研究基金会有限公司
