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
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).
Conditions studied
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
About this study
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).
Interventions
- Device: Accu-Chek SmartGuide CGM Solution — The Accu-Chek SmartGuide CGM solution is used for real-time continuous glucose monitoring (CGM) in the interstitial fluid. It consists of the Accu-Chek SmartGuide device and two smartphone applications (apps): the Accu-Chek SmartGuide app and the Accu-Chek SmartGuide Predict app. The Accu-Chek SmartGuide device contains a CGM sensor pre-assembled in a sensor applicator. It has connectivity to the smartphone that is running the Accu-Chek apps. The Accu-Chek SmartGuide app is the primary display of the real-time glucose values. The Accu-Chek SmartGuide Predict app is an information management tool that further visualizes and analyzes diabetes data from the Accu-Chek SmartGuide device.
- Device: Accu-Chek SmartGuide Sensor and Blinded Apps — The participants in the SMBG control group will wear a SmartGuide sensor with blinded SmartGuide apps intermittently, i.e., during the assessment periods. It is not possible to read out the glucose data from the blinded app, hence neither the SmartGuide app nor the SmartGuide Predict functionalities can be accessed by the participants in this group.
- Device: SMBG Device — With the SmartGuide apps in blinded mode, participants in the SMBG control group will continue using their own SMBG device or they may use the Accu-Chek Instant meter that will be provided for calibration of the SmartGuide device.
Primary outcomes
- Change in the Percentage of Time in Range of a Blood Glucose Concentration of 70 to 180 mg/dL from the Baseline Period to Assessment Period A (Baseline Period (Weeks 1 and 2) and Assessment Period A (Weeks 5 and 6))
Eligibility information
Study locations
- Centrum Badań Klinicznych PI-House sp. z o.o., Gdansk, 80-546 Poland
- Diabetes Technology Center, Jagiellonian University Medical College, Krakow, 31-501 Poland
- NZOZ Neuromed, Kraśnik, 23-204 Poland
- NZOZ Neuromed, Lublin, 20-064 Poland
- Institute of Rural Health, Lublin, 20-090 Poland
- KO-MED Centra Kliniczne Lublin II, Lublin, 30-362 Poland
- BioResearch Group Sp. z o. o., Nadarzyn, 05-830 Poland
- Nbr Polska, Warsaw, 00-710 Poland
- Clinic of Internal Diseases, Endocrinology and Diabetology State Medical Institute MSWiA, Warsaw, 02-507 Poland
- ETG Warszawa, Warsaw, 02-677 Poland
Showing 10 of 19 reported sites. See the official listing for all locations.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-02.