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

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.

Conditions

• Diabetes Mellitus
• Continuous Glucose Monitoring System

Interventions

DEVICE

iCan o3 CGM Continuous Glucose Monitoring System

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.

Sponsors & Collaborators

• Archer Research

  collaborator INDUSTRY

• Sinocare

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-23

Primary Completion

2026-04-30

Completion

2026-06-30

Countries

• Belgium

Study Locations