Type 1 Diabetes Mellitus Clinical Trial
Official title:
Evaluation of Virtual Versus Traditional Study Conduct in a 6-month, Multicenter, Randomized, Open-label, Two-parallel Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus
Primary Objective: To evaluate the effect of virtual approach via novel technologies versus traditional study conduct on glycemic control in terms of glycated hemoglobin (HbA1c). Secondary Objective: To evaluate the appropriate utilization of virtual approach via novel technologies during the study and to assess the effect of the virtual versus traditional study conduct on multiple outcomes in terms of study methodology and diabetes management.
The study had a maximum study duration of 29 weeks, which consisted of a 3-week screening period (including a possible 1-week delay in first investigational medicinal product [IMP] administration after randomization in virtual group due to shipment of IMP and the virtual devices), a 24-week treatment period, and 1-week post-treatment safety follow-up period. ;
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