https://orcid.org/0000-0001-9458-805X
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Ziyi He, Chenxi Wang, Huichuan Tian, Letter to the Editor From He et al: “Dasiglucagon in Children With Congenital Hyperinsulinism up to 1 Year of Age: Results From a Randomized Clinical Trial”, The Journal of Clinical Endocrinology & Metabolism, Volume 110, Issue 5, May 2025, Page e1701, https://doi.org/10.1210/clinem/dgaf101
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To the Editor,
We congratulate De León et al (1) on their significant contribution to the management of congenital hyperinsulinism (CHI) by evaluating dasiglucagon in a vulnerable pediatric population. This trial highlights dasiglucagon's potential to significantly reduce intravenous (IV) glucose requirements, paving the way for more effective and less invasive treatment strategies for CHI. However, we would like to discuss 2 critical methodological issues that merit further exploration.
Firstly, the methodological framework of this study warrants careful examination. The study demonstrated a statistically significant reduction in IV glucose requirements with dasiglucagon compared to placebo (4.3 vs 9.5 mg/kg/min, P = .004). However, the 48-hour placebo-controlled period presents limitations for comprehensive efficacy assessment. Such a short timeframe may not fully reflect the long-term glycemic stability achieved with dasiglucagon or account for variations in patient responses. Moreover, the limited duration might bias results by underestimating potential adverse effects or diminishing the placebo group's outcomes, given that CHI management requires sustained treatment to prevent neuroglycopenia. Longer placebo-controlled evaluations, as seen in prior studies of glucagon analogs, would provide a more nuanced understanding of dasiglucagon's efficacy and safety over time (2). Similarly, Banerjee et al’s (3) comprehensive review of trial designs in CHI highlights the importance of balanced evaluation periods for meaningful outcome assessment.
