1 型糖尿病患者的非严重低血糖：两种不同胰岛素诱导低血糖范围内口服碳水化合物量的随机交叉试验。
Non-severe hypoglycemia in type 1 diabetes: a randomized crossover trial comparing two quantities of oral carbohydrates at different insulin-induced hypoglycemia ranges.
机构信息
Montreal Clinical Research Institute, Montreal, Canada.
Biomedical Sciences Department, Faculty of Medicine, Université de Montréal, Montreal, Canada.
出版信息
Front Endocrinol (Lausanne). 2023 Jun 2;14:1186680. doi: 10.3389/fendo.2023.1186680. eCollection 2023.
AIMS
Non-severe hypoglycemia (NS-H) is challenging for people living with type 1 diabetes (PWT1D) and often results from relative iatrogenic hyper-insulinemia. Current guidelines recommend a one-size-fits-all approach of 15-20 g of simple carbohydrates (CHO) every 15 min regardless of the triggering conditions of the NS-H event. We aimed to test different amounts of CHO to treat insulin-induced NS-H at various glucose ranges.
METHODS
This is a randomized, four-way, crossover study involving PWT1D, testing NS-H treatment outcomes with 16 g vs. 32 g CHO at two plasma glucose (PG) ranges: A: 3.0-3.5 mmol/L and B: <3.0 mmol/L. Across all study arms, participants consumed an additional 16 g of CHO if PG was still <3.0 mmol/L at 15 min and <4.0 mmol/L at 45 min post-initial treatment. Subcutaneous insulin was used in a fasting state to induce NS-H. Participants had frequent venous sampling of PG, insulin, and glucagon levels.
RESULTS
Participants ( = 32; 56% female participants) had a mean (SD) age of 46.1 (17.1) years, had HbA1c at 54.0 (6.8 mmol/mol) [7.1% (0.9%)], and had a diabetes duration of 27.5 (17.0) years; 56% were insulin pump users. We compared NS-H correction parameters between 16 g and 32 g of CHO for range A, 3.0-3.5 mmol/L ( = 32), and range B, <3.0 mmol/L ( = 29). Change in PG at 15 min for A: 0.1 (0.8) mmol/L vs. 0.6 (0.9) mmol/L, = 0.02; and for B: 0.8 (0.9) mmol/L vs. 0.8 (1.0) mmol/L, = 1.0. Percentage of participants with corrected episodes at 15 min: (A) 19% vs. 47%, = 0.09; (B) 21% vs. 24%, = 1.0. A second treatment was necessary in (A) 50% vs. 15% of participants, = 0.001; (B) 45% vs. 34% of participants, = 0.37. No statistically significant differences in insulin and glucagon parameters were observed.
CONCLUSIONS
NS-H, in the context of hyper-insulinemia, is difficult to treat in PWT1D. Initial consumption of 32 g of CHO revealed some advantages at the 3.0-3.5 mmol/L range. This was not reproduced at lower PG ranges since participants needed additional CHO regardless of the amount of initial consumption.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, identifier NCT03489967.
目的
非严重低血糖（NS-H）对 1 型糖尿病患者（PWT1D）来说是一个挑战，通常是由于相对医源性高胰岛素血症引起的。目前的指南建议采用一刀切的方法，即每 15 分钟给予 15-20 克简单碳水化合物（CHO），无论 NS-H 事件的触发条件如何。我们旨在测试不同剂量的 CHO 来治疗不同血糖范围内胰岛素诱导的 NS-H。
方法
这是一项涉及 PWT1D 的随机、四向、交叉研究，测试了在两种血糖（PG）范围下用 16 克和 32 克 CHO 治疗 NS-H 的结果：A：3.0-3.5mmol/L 和 B：<3.0mmol/L。在所有研究臂中，如果初始治疗后 15 分钟 PG 仍<3.0mmol/L 且<4.0mmol/L，则参与者额外摄入 16 克 CHO。在禁食状态下使用皮下胰岛素诱导 NS-H。参与者频繁进行静脉采血以检测 PG、胰岛素和胰高血糖素水平。
结果
参与者（n=32；56%为女性参与者）的平均（SD）年龄为 46.1（17.1）岁，HbA1c 为 54.0（6.8mmol/mol）[7.1%（0.9%）]，糖尿病病程为 27.5（17.0）年；56%为胰岛素泵使用者。我们比较了 16 克和 32 克 CHO 在范围 A（3.0-3.5mmol/L，n=32）和范围 B（<3.0mmol/L，n=29）时的 NS-H 校正参数。A 组 15 分钟时 PG 的变化：0.1（0.8）mmol/L 与 0.6（0.9）mmol/L， = 0.02；B 组：0.8（0.9）mmol/L 与 0.8（1.0）mmol/L， = 1.0。15 分钟时校正发作的参与者百分比：A 组（19%比 47%， = 0.09）；B 组（21%比 24%， = 1.0）。A 组中有 50%的参与者需要第二次治疗，而 B 组中需要第二次治疗的参与者比例为 15%， = 0.001；B 组中有 45%的参与者需要第二次治疗，而 B 组中有 34%的参与者需要第二次治疗， = 0.37。胰岛素和胰高血糖素参数没有观察到统计学上的显著差异。
结论
在高胰岛素血症的情况下，1 型糖尿病患者的 NS-H 难以治疗。最初摄入 32 克 CHO 在 3.0-3.5mmol/L 范围内显示出一些优势。但在较低的 PG 范围内并未再现这一结果，因为无论初始摄入量如何，参与者都需要额外的 CHO。
临床试验注册
ClinicalTrials.gov，标识符 NCT03489967。
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