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Pivotal Studies
Clinical & Scientific Studies

Pivotal Studies
- Performance of the Fifth Generation of a 16-Day Continuous Glucose Monitoring System in Adults with Diabetes.
  
  ^{Chang S, et al.}
  ^{Performance of the Fifth Generation of a 16-Day Continuous Glucose Monitoring System in Adults with Diabetes.}
  ^{Diabetes Technol Ther. 2026 Jan 23:15209156261416870.}
  
  doi: 10.1177/15209156261416870
  Objective: Evaluate Efficacy and Safety of Yuwell Anytime 5Pro CGM System in People with Diabetes
  Research design and methods: Multi-centre prospective study, Adult participants with type 1 and type 2 diabetes at age of 22-77 years, diagnosed with diabetes 1 to 48 years ago, with BMI between 16.9 to 35.9. Readings from Anytime 5Pro CGM matched with readings from reference laboratory device.
  Key outcomes:
  · Overall sensor survival: 98.96%. No technical device malfunctions reported
  · 100% of sensors were successfully inserted and activated
  · Overall MARD: 8.58%
  · Stable system performance across glucose ranges with MARD : 7.14% <54mg/dL; 9.00% 81-180mg/dL; 7.28% >181mg/dL.
  · Stable system performance across sensor wear with MARD: 8.57% at the beginning; 8.30% in the middle; and 8.88% at the end of 16 days sensor wear.
  · True alert rates in factory calibration mode for hypoglycemia: 94.34%; for hyperglycemia: 95.49%.
  · 99.99% of readings were safe for treatment decisions and/or would not lead to inappropriate treatment (within Zone A+B of Consensus Error Grid)
  · iCGM (integrated CGM) metrics met
  · No Serious or Unanticipated Adverse Events observed
  · Users evaluation of the system: 76.39% Excellent; 19.44% Good; 4.17% Fairly good
  Conclusions:
  The Yuwell Anytime 5Pro CGM System showed high performance with stable accuracy and a favourable safety profile. The system met the iCGM performance criteria. Positive participant feedback further supported strong usability and satisfaction.
- Performance and Safety of a 15-Day Real-Time Continuous Glucose Monitoring System in Chinese Adults With Diabetes: A Multicenter Trial
  
  ^{Zhang M. et al.}
  ^{Performance and Safety of a 15-Day Real-Time Continuous Glucose Monitoring System in Chinese Adults With Diabetes: A Multicenter Trial.}
  ^{Journal of Diabetes Science and Technology. 2026;0(0).}
  
  doi:10.1177/19322968261445103
  Objective: Evaluate Efficacy and Safety of Yuwell Anytime 4Pro CGM System in People with Diabetes
  Research design and methods: Multi-centre prospective study, Adult participants with type 1 and type 2 diabetes at age of 18-72 years.
  Readings from Anytime 4Pro CGM matched with readings from reference laboratory device.
  Key outcomes:
  · Overall sensor survival: 99.70%. No technical device defects reported
  · Overall MARD with factory calibration : 8.68% , with weekly user calibration: 8.31%, with daily user calibration: 8.27%
  · Stable system performance in factory calibration mode across glucose ranges with MARD : 9.49% <80mg/dL; 9.17% 80-200mg/dL; 7.59% >200mg/dL. With comparable results and no statistically meaningful deviation observed with daily or weekly user calibrations.
  · Stable system performance across sensor wear with MARD: 8.89% at the beginning; 8.28% in the middle; and 8.85% at the end of 15 days sensor wear.
  · True alert rates in factory calibration mode for hypoglycemia: 95.15%; for hyperglycemia: 96.46%.
  · 99.89% of readings were safe for treatment decisions and/or would not lead to inappropriate treatment (within Zone A+B of Consensus Error Grid)
  · iCGM (integrated CGM) metrics met
  · With consistent results across all parameters and no statistically meaningful deviation between factory, daily, or weekly calibration modes.
  · No Serious Adverse Events observed
  · Users evaluation of the system: 42% Excellent; 58% Fine
  Conclusions:
  The Yuwell Anytime 4Pro CGM System demonstrated high performance with stable, highlevel accuracy and an excellent safety profile.
  The findings confirmed the strong efficacy of the AT4 factorycalibration algorithm. System met iCGM requirements metrics.
  These outcomes were further supported by consistently positive participant feedback, highlighting robust usability and overall satisfaction.
- A Multi-center, Self-Matched Positive Controlled Clinical Investigation Report of Continuous Glucose Monitoring System for the Efficacy and Safety of Real-Time Monitoring of Glucose Concentration in Interstitial Fluid in Patients with Diabetes
  
  ^{Lingong J. et al.}
  ^{A Multi-center, Self-Matched Positive Controlled Clinical Investigation Report of Continuous Glucose Monitoring System for the Efficacy and Safety of Real-Time Monitoring of Glucose Concentration in Interstitial Fluid in Patients with Diabetes.}
  ^{Poctech-QX202206 / V1.0, June 15, 2022. Data on File.}
  ^{Pending publication}
  
  Objective: Evaluate Efficacy and Safety of Yuwell CT3 CGM System in People with Diabetes
  Research design and methods:
  Multi-centre prospective study, Adult participants with type 1 and type 2 diabetes at age of 19-73 years.
  Readings from CT3 CGM matched with readings from reference laboratory device.
  Key outcomes:
  · No technical device defects reported
  · Overall MARD : 9.07% and 20/20 Agreement rate : 91.49%
  · Stable system performance across glucose ranges with MARD : 11.78% <80mg/dL; 9.40% 80-200mg/dL; 7.87% >200mg/dL
  · Stable system performance across sensor wear with MARD: 9.00% at the beginning; 8.15% in the middle; and 10.04% at the end of 14 days sensor wear
  · True alert rates for hypoglycemia: 88.8%; for hyperglycemia: 94.71%
  · 99.95% of readings were safe for treatment decisions and/or would not lead to inappropriate treatment (within Zone A+B of Consensus Error Grid)
  · No Serious Adverse Events observed
  · Users evaluation of the system: 61% Extremely good; 41% Good
  Conclusions:
  The Yuwell CT3 CGM System demonstrated high performance with stable, highlevel accuracy and an excellent safety profile. These results were
  reinforced by consistently positive feedback from study participants, confirming both usability and overall satisfaction.
Clinical & Scientific Studies
- Post-Market Clinical Follow-Up of the CT3 Series Continuous Glucose Monitoring System: A 14-Day Observational Study Assessing Accuracy, Safety, and Glucose Control in Patients with Type 1 and Type 2 Diabetes Mellitus.
  
  ^{Pirags V. et al.}
  ^{Post-Market Clinical Follow-Up of the CT3 Series Continuous Glucose Monitoring System: A 14-Day Observational Study Assessing Accuracy, Safety, and Glucose Control in Patients with Type 1 and Type 2 Diabetes Mellitus.}
  ^{MDCE-TPMW044 2024. Data on File.}
  ^{Pending publication}
  
  Objective: Evaluate the Efficacy, Safety, and Glucose Control of the Yuwell CT3 CGM System in People with Diabetes
  Research design and methods: Multicentre observational study involving adult participants with type 1 and type 2 diabetes, aged 22–86 years; over 47% had additional vascular disorders and/or other comorbid conditions. Glucose readings from the Anytime 4Pro CGM were compared with measurements from the Contour Plus BGM system. Glucometric parameters were analyzed.
  Key outcomes:
  · 98.5% of CT3 sensors inserted and initiated successfully
  · No technical device malfunctions observed
  · 99.83% of readings were safe for treatment decisions and/or would not lead to inappropriate treatment (within Zone A+B of Consensus Error Grid)
  · Average Time in Range (70–180 mg/dL) was 72.48%, and mean Glucose Variability (GV) was 27.22. Both glucometric outcomes met international consensus guidelines.
  · No Serious or Unanticipated Adverse Events observed
  Conclusions:
  The Yuwell Anytime CT3 CGM System demonstrated high performance with stable accuracy. A favorable safety profile was observed in adults with type 1 and type 2 diabetes, including many living with additional coexisting comorbid conditions. Users of the CT3 CGM System achieved international consensus targets for Time in Range and glucose variability.
- Accuracy and performance of the Yuwell Anytime CT3 continuous glucose monitoring device.
  
  ^{Lancaster M. et al.}
  ^{Accuracy and performance of the Yuwell Anytime CT3 continuous glucose monitoring device.}
  ^{Br J Nurs. 2026 Feb 19;35(4):192198.}
  
  doi: 10.12968/bjon.2026.0009. Epub 2026 Feb 18. PMID: 41706553
  Objective: Evaluate the Efficacy of the Yuwell CT3 CGM System in FreeLiving Conditions in People with EarlyStage Type 2 Diabetes
  Research design and methods: Observational study involving adult participants with early stages of type 2 diabetes, aged 32–80 years; and mean BMI of 28.5. Glucose readings from the Yuwell CT3 CGM were compared with measurements from the Accu Chek Instant BGM system used in free-living conditions.
  Key outcomes:
  · Pearson correlation 0.92 (P<0.0001), indicating very strong agreement between CGM and fingerprick values
  · Excellent linear alignment between CGM and bloodglucose measurements across the analysed glucose range
  · No significant concentrationdependent gradient in variation or agreement
  Conclusions:
  Yuwell CT3 CGM showed high accuracy in freeliving conditions among people who were new to both CGM and diabetes treatment.
- Blood Glucose Anomaly Correction and Personalized Short-Term Prediction Based on Continuous Glucose Monitoring Data.
  
  ^{Jiang Z. et al.}
  ^{Blood Glucose Anomaly Correction and Personalized Short-Term Prediction Based on Continuous Glucose Monitoring Data.}
  ^{IEEE Sensors Journal 2025 Oct 1; 25(19):36316-36331,}
  
  doi: 10.1109/JSEN.2025.3598254
  Objective: Develop a machine-learning model to reduce false predictions, noise, and other CGM-related disturbances to accurately identify glucose trends over the next 15, 30, and 45 minutes, enabling more precise automatic insulin-dosing responses.
  Research design and methods: The dataset from the Anytime 5Pro CGM System was used to develop a machine-learning model designed to predict short-term glucose changes-an essential capability for automated insulin delivery (AID) systems.
  Key outcomes:
  · The anomaly-detection model achieved 96.4% accuracy,
  · Clarke error grid analysis showed 99.52% of values in clinically safe zones; for comparison, the public OhioT1DM dataset (used broadly) reached 98.92%.
  Conclusions:
  The model demonstrated superior sensitivity, prediction accuracy, and clinical applicability compared with several existing approaches, offering a robust and practical tool for diabetes management.
- The role of combined training timing strategies in mitigating the dawn phenomenon in older adults with type 2 diabetes in Nanjing, China: a randomized controlled trial.
  
  ^{Yibo G. et al.}
  ^{The role of combined training timing strategies in mitigating the dawn phenomenon in older adults with type 2 diabetes in Nanjing, China: a randomized controlled trial.}
  ^{Preventive Medicine Reports, Volume 65, 2026, 103456, ISSN 2211-3355}
  
  http://doi.org/10.1016/j.pmedr.2026.103456.
  Objective: Evaluate the effectiveness of a novel periodic exercise protocol on the dawn phenomenon in patients with type 2 diabetes and examine the impact of different inter-cycle rest days.
  Research design and methods: Randomised controlled trial involving participants aged 60–75 years with type 2 diabetes and dawn phenomenon. The exercise intervention and data collection, including Yuwell CT3 CGM readings, were conducted from October 2023 to January 2024. All participants provided informed consent and were randomized.
  Key outcomes:
  · All intervention groups showed significant improvements in glucose and lipid parameters
  · Dawn phenomenon decreased below 19.89 mg/dL in all exercise groups
  · The 1day rest group showed the earliest and most pronounced improvements, with a continuous decline in the dawn phenomenon.
  Conclusions:
  The protocol improved both the dawn phenomenon and metabolic outcomes. Shorter rest intervals yielded more durable effects, indicating a homeostatic influence on glycemic response.