Evaluation of Accu-Chek SmartGuide Continuous Glucose Monitoring Versus Self-Monitoring in Adults with Type 1 and Type 2 Diabetes Using Insulin Injections

What this Trial Is About

Researchers are evaluating the impact of the Accu-Chek SmartGuide continuous glucose monitoring CGM system compared with traditional self-monitoring of blood glucose SMBG in adults with Type 1 or insulin-dependent Type 2 diabetes who use multiple daily insulin injections. This open-label, randomized, multi-center clinical device study aims to see how the CGM system affects the time participants blood glucose levels stay within the target range of 70-180 mgdL. The study is sponsored by Hoffmann-La Roche and focuses on measuring blood glucose control improvements. Participants are assigned to one of two groups one uses the Accu-Chek SmartGuide CGM solution, which includes a sensor applicator and smartphone apps providing real-time glucose data and analysis the other group continues standard care with SMBG devices while wearing a blinded CGM sensor intermittently during assessment periods. The blinded sensors record data without providing feedback to participants. The study includes baseline, assessment periods A, B, and C occurring over several weeks to compare glucose control over time. During the study, participants will have their blood glucose monitored continuously or through SMBG devices, complete questionnaires on diabetes distress and fear of hypoglycemia, and have laboratory tests including HbA1c at multiple time points. Researchers will track various glucose metrics such as time in range, hypoglycemia events, and glycemic variability. The study duration extends through several assessment periods up to approximately 26 weeks, with ongoing evaluations to assess the usability and impact of the CGM system on diabetes management.

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