Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism

Adverse Events

Time frame · Baseline through treatment completion, up to 3 years

Number of adverse events occurring up to Month 1, Month 1 to Month 3 and in each 3-month period for the first year; subsequent years will have longer periods assigned for analysis

Amount of gastric carbohydrates administered to treat hypoglycemia

Time frame · Baseline through treatment completion, up to 3 years

Total amount of gastric carbohydrates administered via nasogastric tube or gastrostomy per week to treat hypoglycemia

Nasogastric (NG) tube or gastrostomy removal

Time frame · Baseline through treatment completion, up to 3 years

Time to removal of NG tube or gastrostomy

Pancreatic surgery

Time frame · Baseline through treatment completion, up to 3 years

Time to pancreatic surgery (sub-total or total pancreatectomy)

Time in hypoglycemia

Time frame · Baseline through treatment completion, up to 3 years

Continuous glucose monitoring (CGM) percent time \<70 mg/dL (3.9 mmol/L)

Hypoglycemia episodes

Time frame · Baseline through treatment completion, up to 3 years

Rate of CGM-detected hypoglycemia episodes \<70 mg/dL (3.9 mmol/L) for 15 minutes or more

Clinically significant episodes of hypoglycemia

Time frame · Baseline through treatment completion, up to 3 years

Rate of clinically significant CGM-detected hypoglycemia episodes \<54 mg/dL (3.0 mmol/L) for 15 minutes or more

Gastric carbohydrate administrations

Time frame · Baseline through treatment completion, up to 3 years

Number of gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia

Nightly gastric carbohydrate administrations

Time frame · Baseline through treatment completion, up to 3 years

Number of nightly (midnight to 6 am) gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia

Extent of hypoglycemia

Time frame · Baseline through treatment completion, up to 3 years

Extent of hypoglycemia (area over the glucose curve \[AOCglucose\] below 70 mg/dL \[3.9 mmol/L\]) as measured by continous glucose monitoring (CGM)

Extent of clinically significant hypoglycemia

Time frame · Baseline through treatment completion, up to 3 years

Extent of hypoglycemia (area over the glucose curve \[AOCglucose\] below 54 mg/dL \[3.0 mmol/L\]) as measured by continous glucose monitoring (CGM)