Pan-European proof-of-concept study comparing Decentralised Clinical Trial (DCT) and hybrid approaches to conventional clinical trial approaches in patients with Type 2 diabetes mellitus treated with Toujeo®

Type 2 diabetes mellitus (T2DM)

Objective 1: Time to enrolment from Site activation until last participant enrolled; Proportion of participants completing the study period; Various diversity aspects such as race, ethnicity, socioeconomic status etc. Objective 2: Time from event occurrence to collection AE/SAE in the eDiary or eCRF. Adherence to the daily insulin injection by means of eDiary analysis in percentage of days of documented intake until participant's EOT

HbA1c change from baseline to Week 24; HbA1c change from baseline to Week 12; Fasting SMPG change from baseline to Week 24; Fasting SMPG change from baseline to Week 12; Percentage (%) of participants reaching HbA1c level <7% (53 mmol/mol) at Week 12 and Week 24; Percentage (%) of participants reaching fasting SMPG target of 80–130 mg/dL (4.4 -7.2 mmol/L) at Week 12 and 24; Percentage (%) of participants reaching target HbA1c <7% (53 mmol/mol) Week 12 and Week 24 without severe and/or confirmed

No related papers found yet.

Denmark, Germany, Italy, Poland, Spain