To Evaluate the Change in Glucose Parameters in Adult Patients With Type 1 or Type 2 Diabetes Fro… (NCT06904846) | Clinical Trial Compass
By InvitationNot Applicable
To Evaluate the Change in Glucose Parameters in Adult Patients With Type 1 or Type 2 Diabetes From Europe Using the iCan o3 CGM System for 60 Days Period
Belgium70 participantsStarted 2025-04-23
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patient age is between 18 and 75 years old. Patient age is between 18 and 75 years old.
✓. Patient is clinically diagnosed with diabetes for at least 6 months (all treatment modalities are allowed).
✓. Patient has a Hemoglobin A1c (HbA1c) of \> 7,5%.
✓. Patient is sensor naive.
✓. Patient is willing to wear the device on the abdomen for the whole study period.
✓. Patient has a stable (unchanged) treatment regimen for at least 3 months. "Stable treatment regimen" is considered no changes in prescribed number of insulin deliveries a day, and a change in total daily insulin dose of less than 10%. Patients currently taking glucagon-like peptide-1 (GLP1) analogs before the study can be included.
✓. Patient has a compatible smartphone.
✓. Patient shows sufficient skills using a smartphone and apps, as judged by the investigator.
. Patient was hospitalized because of hyperglycemia/ketoacidosis within the last 6 months.
✕. Patient was hospitalized because of hypoglycemia within the last 6 months.
✕. Patient has a condition which may predispose him/her to hypoglycemia including, but not limited to, thyroid disease which is not well controlled, adrenal insufficiency, high dose steroid use in recent past or planned during study, significant renal or liver disease.
✕. Patient has a planned magnetic resonance imaging (MRI), Computed Tomography (CT) scan or diathermic procedure during the period of sensor wear.
✕. Patient with a significant medical or psychiatric disorder, or use of a medication which will affect the application of the protocol judged by the investigator.
✕. Patient with cognitive difficulties that may impair the ability to follow the protocol judged by the investigator.
✕. Patient is critically ill.
✕. Patient has a coagulation disorder or takes heparin-like antiplatelet medication.