Montreal Clinical Research Institute, Montreal, Canada.
Biomedical Sciences Department, Faculty of Medicine, Université de Montréal, Montreal, Canada.
Front Endocrinol (Lausanne). 2023 Jun 2;14:1186680. doi: 10.3389/fendo.2023.1186680. eCollection 2023.
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.
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.
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.
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.
ClinicalTrials.gov, identifier NCT03489967.
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。
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。
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。
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。
ClinicalTrials.gov，标识符 NCT03489967。
