Lin Yu Kuei, Ye Wen, Hepworth Emily, Agni Annika, Matus Austin M, Flatt Anneliese J, Shaw James A M, Rickels Michael R, Amiel Stephanie A, Speight Jane
Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, USA.
Diabetologia. 2025 Feb;68(2):433-443. doi: 10.1007/s00125-024-06310-5. Epub 2024 Oct 30.
AIMS/HYPOTHESIS: We aimed to: (1) externally validate the five-item Hypoglycaemia Awareness Questionnaire (HypoA-Q) impaired awareness subscale (HypoA-Q IA); (2) examine how impaired awareness of hypoglycaemia (IAH) relates to the risk of severe hypoglycaemia and level 2 hypoglycaemia; and (3) identify factors associated with IAH.
Nationwide survey of T1D Exchange registrants was conducted to collect data on demographics, 6 month severe-hypoglycaemia history, hypoglycaemia awareness status (via HypoA-Q IA, the Gold instrument and the Clarke instrument) and continuous glucose monitor (CGM) measures. The Clarke hypoglycaemia awareness factor (Clarke-HAF) was calculated to exclude severe-hypoglycaemia history items. Analyses included Cronbach's α, Spearman correlations and logistic regression.
Valid survey responses were collected from N=1580 adults with type 1 diabetes (median age, 44 years; 52% female participants; median HbA, 48 mmol/mol [6.5%]). Of these, 94% of participants were using CGMs and 69% were using hybrid closed-loop (HCL) systems; 30% had at least one severe-hypoglycaemia episode in the past 6 months. The HypoA-Q IA had satisfactory internal reliability (α=0.79) and construct validity. Higher HypoA-Q IA scores were independently associated with greater risk of severe hypoglycaemia (p<0.001), performing comparably to the Gold instrument and the Clarke-HAF instrument. HypoA-Q IA-determined IAH was independently associated with 88% higher odds of developing severe hypoglycaemia (p<0.001) and twofold higher odds for spending ≥1% of time in level 2 hypoglycaemia (p=0.011). Higher age and longer diabetes duration were associated with higher IAH risk (p<0.001). CGM and HCL use was associated with lower IAH risk (p<0.001).
CONCLUSIONS/INTERPRETATION: The HypoA-Q IA is a brief, valid and reliable tool for assessing IAH in today's technology-oriented era. IAH was independently associated with severe hypoglycaemia and level 2 hypoglycaemia in a cohort with high prevalence of advanced diabetes technology use and HbA within the recommended range. CGM and HCL use was related to lower IAH risk.
目的/假设:我们旨在:(1)对外验证五项低血糖意识问卷(HypoA-Q)的意识受损子量表(HypoA-Q IA);(2)研究低血糖意识受损(IAH)与严重低血糖和2级低血糖风险之间的关系;(3)确定与IAH相关的因素。
对T1D Exchange注册者进行全国性调查,以收集有关人口统计学、6个月严重低血糖病史、低血糖意识状态(通过HypoA-Q IA、金标准仪器和克拉克仪器)以及连续血糖监测(CGM)测量的数据。计算克拉克低血糖意识因子(Clarke-HAF)以排除严重低血糖病史项目。分析包括Cronbach's α、Spearman相关性和逻辑回归。
收集了N = 1580名1型糖尿病成年人的有效调查回复(中位年龄44岁;52%为女性参与者;中位糖化血红蛋白[HbA]为48 mmol/mol[6.5%])。其中,94%的参与者使用CGM,69%使用混合闭环(HCL)系统;30%在过去6个月中至少有一次严重低血糖发作。HypoA-Q IA具有令人满意的内部信度(α = 0.79)和结构效度。较高的HypoA-Q IA得分与严重低血糖风险增加独立相关(p < 0.001),与金标准仪器和Clarke-HAF仪器表现相当。由HypoA-Q IA确定的IAH与发生严重低血糖的几率高88%独立相关(p < 0.001),在2级低血糖中花费≥1%时间的几率高两倍(p = 0.011)。年龄较大和糖尿病病程较长与IAH风险较高相关(p < 0.001)。使用CGM和HCL与较低的IAH风险相关(p < 0.001)。
结论/解读:在当今技术导向的时代,HypoA-Q IA是一种评估IAH的简短、有效且可靠的工具。在一个先进糖尿病技术使用率高且HbA在推荐范围内的队列中,IAH与严重低血糖和2级低血糖独立相关。使用CGM和HCL与较低的IAH风险相关。