Sinocare iCan CGM Fully Meets iCGM Accuracy Standards! Consistently Reliable in Both Hospital and Home Settings

The rapid advancement of Continuous Glucose Monitoring (CGM) technology is reshaping diabetes management paradigms—blood glucose monitoring has evolved from intermittent measurements to a 24-hour, continuous, and dynamic assessment system.As the application of CGM in clinical treatment decision-making deepens, its accuracy and stability in real-world usage scenarios have become key clinical concerns.

The challenge of CGM lies not only in "measuring accurately" but also in consistently providing reliable data during blood glucose fluctuations and within critical risk ranges! For instance, excessive deviations in CGM readings may mask hypoglycemia risks or overstate hyperglycemia severity, thereby affecting clinical judgment and patients' self-management.A CGM system can only serve as a reliable tool to support clinical treatment decisions when it continuously delivers accurate data—regardless of whether blood glucose is relatively stable, fluctuating rapidly, or within critical risk ranges such as hypo/hyperglycemia—and maintains consistent performance throughout the entire wearing period.

Research on CGM Reliability and Safety: From Hospital to Daily Life

Against this backdrop, a randomized, multicenter performance evaluation study was conducted to systematically assess the accuracy, stability, and safety of the Sinocare iCan i3 CGM. The study enrolled adult patients with Type 1 Diabetes Mellitus (T1DM) and/or Type 2 Diabetes Mellitus (T2DM) receiving insulin therapy, covering 6 research centers. This article presents data from the Ulm Center in Germany—the center with the largest number of enrolled subjects, ensuring highly representative results. Relevant findings were recently published in Diabetes Therapy. Notably, the study involved Professor Guido Freckmann, Chairman of the CGM Working Group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), providing an internationally authoritative, evidence-based foundation for the accuracy evaluation of the Sinocare iCan i3 CGM.

Source: DOI: 10.1007/s13300-025-01832-6

At the Ulm Center, 35 subjects [T1DM (n=31), T2DM (n=4)] wore the Sinocare iCan i3 CGM continuously for 15 days (consistent with the sensor's intended wear duration).

Table. Subject Characteristics (N=35)

As shown, the subjects exhibited significant blood glucose fluctuations and relatively low average levels, closely mimicking real-world complex clinical scenarios and enabling robust assessment of the CGM's actual performance. Subjects were randomly assigned to two groups based on diabetes type (T1DM/T2DM):

• Group A: 2 CGM sensors worn on the abdomen, 1 on the arm;
• Group B: 1 CGM sensor worn on the abdomen, 2 on the arm.

Each subject self-inserted a total of 3 Sinocare iCan i3 CGM sensors. For each insertion site, the first-implanted CGM was designated as the primary sensor for subsequent performance analysis, while the others served as backups or controls.

Hospital Visit Phase:

Over the 15-day study period, 4 hospital visits were scheduled to cover the entire CGM wearing cycle, assessing performance stability throughout the sensor's service life: Initial Stage (1 follow-up visit: Days 1-2) — Middle Stage (2 follow-up visits: Days 4-6, Days 8-11) — Final Stage (1 follow-up visit: Days 14-15).

During each hospital visit, subjects underwent frequent blood glucose sampling via an indwelling intravenous catheter:

• Under normal conditions: Blood glucose samples were collected every 15 minutes;
• When blood glucose < 3.9 mmol/L or > 16.7 mmol/L: Sampling frequency was increased to every 5 minutes to enhance safety and reference data accuracy;
• Single hospital monitoring lasted up to 10 hours.

All plasma glucose samples were measured using the YSI 2300 Stat Plus Glucose Analyzer as the gold standard for comparison. Blood ketone levels were monitored before and after frequent sampling to ensure metabolic safety.

Subsequently, researchers conducted standardized blood glucose manipulation experiments under medical supervision, including hypoglycemia (< 3.9 mmol/L) or hyperglycemia (> 16.7 mmol/L), to evaluate CGM's accuracy and reliability systematically across different blood glucose ranges and rapid fluctuation conditions.

Free Living Phase:

During non-hospital visit periods, subjects lived freely or were hospitalized, managing their diabetes according to their daily routines and established treatment plans. The Sinocare iCan i3 CGM continuously recorded glucose data while remaining in blinded mode.

After 15 days of wear, CGM sensors were uniformly removed by the research center, and follow-up evaluations were completed. It is important to emphasize that this study adopted a high-specification evaluation system oriented toward regulatory standards. All CGM accuracy analyses were performed in accordance with the FDA Integrated CGM (iCGM) control standards, including the following assessment content:

Table. Assessment Content

Sinocare iCan i3 CGM Meets iCGM Accuracy and Safety Standards!

A total of 107 CGM sensors were used in the study, yielding 5,459 and 4,872 pairs of CGM-reference blood glucose data for abdominal and arm placements, respectively. Using these paired data, researchers systematically analyzed the point accuracy, trend accuracy, and wearing stability of the Sinocare iCan i3 CGM, with key results summarized below:

Sinocare iCan i3 CGM: Meets All FDA iCGM Accuracy and Safety Standards!

Table. Sinocare iCan i3 CGM complies with all specific iCGM control requirements for accuracy and safety

The study demonstrated that regardless of abdominal or arm placement, the Sinocare iCan i3 CGM passed all iCGM accuracy-specific control requirements, including accuracy within hypoglycemia (< 3.9 mmol/L) and hyperglycemia (> 10.0 mmol/L) ranges, as well as safety thresholds.

Sinocare iCan i3 CGM: Consistent Performance Between Abdominal and Arm Placement, Continuously Accurate and Stable Across All Blood Glucose Ranges and Wearing Periods!

MARD Value

Figure. [Left: MARD values of Sinocare iCan i3 CGM during 4 hospital visits (Early-Mid-Early-Mid-Late); Right: Consensus Error Grid Analysis of Sinocare iCan i3 CGM vs. reference blood glucose (Abdomen, Upper Arm)]

Consensus Error Grid Analysis

• MARD Compliance:

Abdomen: 9.4%; Arm: 9.8%; consistently stable throughout the 15-day wear period.

• Consensus Error Grid Analysis:

100% of data fell within Zones A+B for both abdominal and arm placements, indicating high CGM monitoring precision that meets clinical usage requirements.

• 20/20% Agreement Rate:

Abdomen: 95.5%; Arm: 95.3%; maintained high agreement across all blood glucose ranges, ensuring reliable monitoring of both hypo- and hyperglycemia (> 95%).

Table. 20/20% Agreement Rate of Sinocare iCan i3 CGM

Sinocare iCan i3 CGM: Excellent Safety and Minimal Pain!

To comprehensively evaluate the safety and wearing comfort of the Sinocare iCan i3 CGM in real-world use, researchers summarized adverse events associated with all implanted sensors and recorded insertion/removal pain using the Visual Analog Scale (VAS). Key indicators are shown below:

Table. Safety and Pain-Related Indicators

The Sinocare iCan i3 CGM is safe and reliable for both abdominal and arm placement, with only mild adverse events. Insertion and removal pain is minimal, and abdominal insertion is particularly comfortable—almost no pain reported—demonstrating excellent wear tolerance and patient acceptance.

Summary of Sinocare iCan i3 CGM Study Results

Table. Comprehensive Performance Summary of Sinocare iCan i3 CGM

Collectively, the study data demonstrate that the Sinocare iCan i3 CGM delivers excellent point and trend accuracy regardless of abdominal or arm placement, with stable and continuously reliable performance. The sensor’s strong adhesion and continuous data output confirm its ability to stably and accurately capture blood glucose changes during 15-day continuous monitoring, providing solid, reliable clinical data support for diabetes management.

Sinocare iCan i3 CGM: An Accurate, Continuous, and Reliable Tool for Diabetes Management

This study comprehensively evaluated the performance of the Sinocare iCan i3 CGM in mixed real-life and hospital settings, revealing outstanding performance in precision, stability, and safety. The results indicate that the Sinocare iCan i3 CGM not only meets FDA iCGM standards but also excels in multiple key indicators! Whether worn on the abdomen or arm, its point accuracy (MARD < 10%) and trend accuracy (highly consistent RoC) meet clinical requirements, maintaining stable and reliable performance over the 15-day wear period. Additionally, the CGM’s high adhesion rate and continuous data output further validate its reliability in dynamic blood glucose monitoring.

From a patient experience perspective, the Sinocare iCan i3 CGM causes minimal pain during insertion and removal—abdominal insertion is significantly more comfortable than arm placement—enhancing patient wear tolerance. Notably, all adverse events reported in the study were mild, with no serious reactions observed, further confirming the device’s safety.

Overall, the Sinocare iCan i3 CGM’s comprehensive performance in precise monitoring, stability maintenance, patient comfort, and safety positions it as a reliable tool for diabetes management, meeting the technical standards of mainstream international CGM systems! In the future, as CGM technology continues to advance and become more accessible, the application of the Sinocare iCan i3 CGM will undoubtedly provide solid support for personalized treatment and long-term management of diabetes patients, playing an increasingly important role in clinical practice.

References:

Jendrike N, Link M, Öter S, Fei J, Zheng J, Gao F, Gao A, Zhu S, Shi L, Strange P, Flacke F, Eichenlaub M, Freckmann G. Performance of a New Continuous Glucose Monitoring System in German Adults Living with Diabetes. Diabetes Ther. 2025 Dec 29. doi: 10.1007/s13300-025-01832-6. Epub ahead of print.