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
Untreated adrenal or thyroid insufficiency
Severe visual impairment
Significant renal impairment: eGFR <30 ml/min within last one year
Serious acute or chronic concomitant disease or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject
Hoffmann-La Roche
Lead sponsor
Roche Diabetes Care
Collaborator