An Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism

This study is an important follow-up to earlier research and is focusing on children who have a rare condition called congenital hyperinsulinism (CHI). Children with CHI produce too much insulin, which can cause their blood sugar to drop dangerously low. This can be very serious and lead to problems if not managed well.

The study is looking at a medicine called dasiglucagon. This medicine aims to help control blood sugar levels in these children. The main point of this study is to understand the long-term safety of dasiglucagon, meaning they want to know if it causes any harmful effects when used for a longer time. They will carefully record all side effects, no matter how small.

Beyond safety, the study also wants to see how well dasiglucagon works. Researchers will be looking at several things, such as how much sugar children need through feeding tubes to prevent low blood sugar, and if they can stop using these tubes. They will also check if the medicine might reduce the need for surgery on the pancreas. They'll also use special monitors (CGM) to track blood sugar levels continuously, helping them understand how stable blood sugar is and how often low blood sugar episodes happen.