To use a minimally invasive yet objective method of assessing the frequency of hypoglycaemia, patients will be required to wear a continuous glucose monitoring (CGM) device, and families will also be asked to perform self-monitoring of blood glucose (SMBG).
The end-of-treatment visit from the lead-in trial will serve as the baseline visit for the present trial, and any post-treatment follow-up scheduled for patients in the lead-in trial will be redundant if they are enrolled in the present trial by the time of the scheduled follow-up visit.
Patients will be seen at Month 1, 3, and 6 and every 3 months thereafter. Details on dasiglucagon and other relevant data will be collected in an electronic diary at specified intervals and reviewed by site staff. Patients will be allowed to remain in the trial until approval of dasiglucagon