Kowalczyk Emilia, Dżygało Katarzyna, Szypowska Agnieszka
Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital of the Medical University of Warsaw, Warsaw, Poland.
Department of Pediatrics, Medical University of Warsaw, Warsaw, Poland.
Trials. 2022 Mar 29;23(1):240. doi: 10.1186/s13063-022-06173-4.
Postprandial hyperglycemia (PPH) is a common clinical problem among patients with type 1 diabetes (T1D), which is related to high glycemic index (h-GI) meals. The main problem is linked to high, sharp glycemic spikes following hypoglycemia after h-GI meal consumption. There is a lack of effective and satisfactory solutions for insulin dose adjustment to cover an h-GI meal. The goal of this research was to determine whether a Super Bolus is an effective strategy to prevent PPH and late hypoglycemia after an h-GI meal compared to a Normal Bolus.
A total of 72 children aged 10-18 years with T1D for at least 1 year and treated with continuous subcutaneous insulin infusion for more than 3 months will be enrolled in a double-blind, randomized, crossover clinical trial. The participants will eat a h-GI breakfast for the two following days and receive a prandial insulin bolus in the form of a Super Bolus 1 day and a Normal Bolus the next day. The glucose level 90 min after the administration of the prandial bolus will be the primary outcome measure. The secondary endpoints will refer to the glucose levels at 30, 60, 120, 150, and 180 min postprandially, the area under the blood glucose curve within 180 min postprandially, peak glucose level and the time to peak glucose level, glycemic rise, the mean amplitude of glycemic excursions, and the number of hypoglycemia episodes.
There are still few known clinical studies on this type of bolus. A Super Bolus is defined as a 50% increase in prandial insulin dose compared to the dose calculated based on the individualized patient's insulin-carbohydrate ratio and a simultaneous suspension of basal insulin for 2 h. Our patients reported the best experience with such a combination. A comprehensive and effective solution to this frequent clinical difficulty of PPH after an h-GI meal has not yet been found. The problem is known and important, and the presented solution is innovative and easy to apply in everyday life.
ClinicalTrials.gov NCT04019821.
餐后高血糖（PPH）是1型糖尿病（T1D）患者常见的临床问题，与高血糖指数（h-GI）膳食有关。主要问题与食用h-GI膳食后低血糖后的高血糖急剧峰值有关。对于覆盖h-GI膳食的胰岛素剂量调整，缺乏有效且令人满意的解决方案。本研究的目的是确定与常规大剂量注射相比，超级大剂量注射是否是预防h-GI膳食后PPH和晚期低血糖的有效策略。
总共72名年龄在10至18岁、患有T1D至少1年且接受持续皮下胰岛素输注超过3个月的儿童将被纳入一项双盲、随机、交叉临床试验。参与者将在接下来的两天吃h-GI早餐，并在一天接受超级大剂量注射形式的餐时胰岛素大剂量注射，第二天接受常规大剂量注射。餐时大剂量注射给药后90分钟的血糖水平将作为主要结局指标。次要终点将涉及餐后30、60、120、150和180分钟时的血糖水平、餐后180分钟内血糖曲线下面积、血糖峰值水平和血糖峰值出现时间、血糖上升、血糖波动平均幅度以及低血糖发作次数。
关于这种类型的大剂量注射，已知的临床研究仍然很少。超级大剂量注射被定义为与根据个体患者胰岛素-碳水化合物比例计算的剂量相比，餐时胰岛素剂量增加50%，同时基础胰岛素暂停2小时。我们的患者报告了这种组合的最佳体验。尚未找到针对h-GI膳食后这种常见临床难题的全面有效解决方案。这个问题是已知且重要的，所提出的解决方案具有创新性且易于在日常生活中应用。
ClinicalTrials.gov NCT04019821。
