Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Trial Parameters
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Hematocrit greater than 10% below the lower limit of normal * Pregnancy (lack of negative pregnancy test - except in case of menopause, sterilization or hysterectomy - self-reported), planned pregnancy, or breast feeding * Allergic to the adhesive (glue or tape) * Skin diseases (e.g. psoriasis vulgaris, ba