Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range of 70 - 180 mg/dl Compared to SMBG
This is an open label, two-arm, randomized multi-center clinical device study in adult subjects with Type 1 diabetes (T1D) or insulin-dependent Type 2 diabetes (T2D) on a multiple daily injection (MDI) regime. The goal of the study is to investigate the impact of the Accu-Chek SmartGuide CGM solution on the change in overall time in range (TIR) of blood glucose concentrations of 70-180 mg/dl compared with that using self-monitoring of blood glucose (SMBG).
• Type 1 Diabetes mellitus (T1D) or Type 2 Diabetes mellitus (T2D) diagnosed at least 12 months prior to screening, using multiple daily injection (MDI) regime for at least six months prior to screening
• Performing SMBG, no CGM/flash glucose monitoring (FGM) use during the last six months prior screening
• HbA1c ≥8% and ≤10% based on analysis from a local laboratory