UZA ANTWERP UZA Dienst Endocrinologie
Antwerp, Belgium
NCT Number: NCT06904846
This study is a post-market, prospective, interventional, multicenter clinical trial designed to evaluate the impact of the iCan O3 Continuous Glucose Monitoring (CGM) System on glycemic control in adults with Type 1 (T1D) or Type 2 Diabetes (T2D). Coordinated by Prof. Dr. Christophe De Block at Universitair Ziekenhuis Antwerpen (UZA), Belgium, and sponsored by Changsha Sinocare Inc., the study aims to assess changes in glucometric parameters over 60 days. The primary objective is to demonstrate an improvement in Time in Range (TIR) compared to baseline, measured during an initial 15-day blinded period using self-monitored blood glucose (SMBG) assessed by the iCan O3 CGM System. Secondary objectives include evaluating the system's efficacy, safety, and usability and patient-reported outcomes such as treatment satisfaction and diabetes management impact. The study will enroll 70 patients aged 18-75 with HbA1c >7.5%, stable treatment regimens, and smartphone proficiency while excluding individuals with recent diabetes-related hospitalizations, severe comorbidities, or conflicting trial participation. The study timeline spans from February 2025 to September 2025, with patients undergoing a 15-day blinded period followed by a 45-day unblinded period where real-time CGM data is accessible. Key endpoints include improvements in TIR, Time Below Range (TBR), Time Above Range (TAR), mean glucose levels, glucose variability, and patient-reported outcomes and safety metrics such as device deficiencies and adverse events. Risks, including skin irritation and delayed glucose readings, will be mitigated through patient training and safety protocols. Anticipated benefits include improved glycemic control, reduced reliance on fingerstick testing, and enhanced quality of life. Data will be collected from CGM metrics, questionnaires, and adverse event logs, with statistical analysis comparing baseline and post-intervention outcomes. The study adheres to ethical standards and EU MDR 2017/745 regulations, aiming to validate the iCan O3 CGM System's clinical utility in real-world diabetes management.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Antwerp, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A continuous Glucose Monitoring System (CGM System) is a real-time, continuous glucose monitoring device indicated for the management of diabetes for adult persons (age 18 and older). It is intended to replace finger prick blood glucose testing for diabetes treatment decisions. The CGM System also shows trends and tracks patterns, and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the CGM System results should be based on the glucose trends and several sequential readings over time.
The CGM System can be used in conjunction with smart devices with corresponding applications (apps) where the user manually controls actions for therapy decisions. During this study, Self-Monitoring Blood Glucose (SMBG) assessed by an iCan o3 CGM System blinded to the patient for 15 days as the baseline and unblinded observation period using an iCan o3 CGM System for 45 days occurs.
Time frame: 60 days
The increased percentage of Time in range (TIR) compare to the baseline period
Sinocare
Industry
Prospective Post-market Clinical Follow-up (PMCF) Study Aimed to Evaluate the Change in Glucometric Parameters in Adult Patients With Type 1 or Type 2 DiabETes From Europe Using the iCan o3 CGM SysTem for a 60-day Period
Acronym: DETECT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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