drugset / Trial / NCT03260868

Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)

NCT03260868

Phase 4 Terminated 15 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2017-09-19
Primary completion
2018-11-22
Completion
2018-11-22

Drugs

EvaluationDrugModalityDoseRoute
Background Insulin Lispro Protein / enzyme biologic Subcutaneous
Background Insulin glulisine Protein / enzyme biologic Subcutaneous
Background insulin aspart Protein / enzyme biologic Subcutaneous
Background insulin glargine Protein / enzyme biologic Subcutaneous