Yadav Arti, Kumar Rakesh, Dayal Devi, Yadav Jaivinder, Pattanaik Smita, Patil Amol
Pediatric Endocrinology and Diabetes Unit, Department of Pediatrics, Advanced Pediatrics Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.
Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.
Indian J Pediatr. 2025 Mar;92(3):235-242. doi: 10.1007/s12098-023-04844-x. Epub 2023 Oct 21.
To study the effect of postmeal Fast-acting insulin Aspart (Fiasp) on the frequency of hypoglycemia compared to premeal injection among preschool children with type 1 diabetes.
A single-center trial was conducted among 65 pre-school children (6 mo to 6 y) with Type 1 diabetes for at least 6 mo, on multiple daily insulin injections. Children were randomized to receive their meal bolus postmeal or premeal for the first 3 mo, followed by cross-over at 3 mo. The two groups were compared at the end of 6 mo for the change in frequency of hypoglycemia and hyperglycemia, HbA1c, glycemic variability, and parental satisfaction. Ten children (5 in each group) underwent pharmacokinetic studies. The trial was approved by Institutional Ethics Committee and registered with the Controlled Trial Registry of India vide no CTRI/2020/10/028750.
Fifty-four children completed the study, with 27 children in each group. There were no significant differences in the frequency of clinical (p = 0.921), severe (p = 0.167) or serious (p = 0.753) hypoglycemia in the two groups. There were no differences in secondary outcome parameters and pharmacokinetics.
The premeal or postmeal injection of Fiasp does not affect the frequency of hypoglycemia or other glycemic control parameters among pre-school children with Type 1 diabetes.
The trial is registered with the Controlled Trial Registry of India vide no CTRI/2020/10/028750.
研究与餐前进注相比，餐时注射速效胰岛素门冬氨酸（Fiasp）对1型糖尿病学龄前儿童低血糖发生频率的影响。
对65名1型糖尿病学龄前儿童（6个月至6岁）进行了一项单中心试验，这些儿童接受每日多次胰岛素注射至少6个月。儿童被随机分为两组，在最初3个月内分别于餐后或餐时接受餐时大剂量胰岛素注射，3个月后进行交叉。在6个月末比较两组低血糖和高血糖发生频率的变化、糖化血红蛋白（HbA1c）、血糖变异性及家长满意度。10名儿童（每组5名）进行了药代动力学研究。该试验经机构伦理委员会批准，并在印度对照试验注册中心注册，注册号为CTRI/2020/10/028750。
54名儿童完成了研究，每组27名。两组在临床低血糖（p = 0.921）、严重低血糖（p = 0.167）或严重低血糖（p = 0.753）发生频率上无显著差异。次要结局参数和药代动力学方面也无差异。
餐时或餐前进注Fiasp对1型糖尿病学龄前儿童的低血糖发生频率或其他血糖控制参数无影响。
该试验在印度对照试验注册中心注册，注册号为CTRI/2020/10/028750。
