Subjects in the upper arm group will have a sensor of the CGM System inserted on each arm (left and right upper arm). Subjects in the abdomen group will have 2 sensors inserted, one on each side of the abdomen (left and right abdomen) The sensors will be placed for 29 days. After sensor insertion, the CGM system should be calibrated with capillary blood glucose readings from a self-monitoring blood glucose meter。
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
144
Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
%20/20 agreement between the test device readings and the EKF readings: %20/20 = A + B
A = the proportion of the CGM system values that were within ±20% of paired EKF values \>4.4mmol/L (\>80 mg/dL) B = the proportion of the CGM system values that were within ±1.1mmol/L (20mg/dL) of paired EKF values ≤4.4mmol/L (≤80mg/dL)
Time frame: up to 29 days
Proportion of readings in Region A + Region B of Clarke Error Grid
Analyze the proportion of readings in each region (Region A, B, C D and E). Readings in Region A are clinically accurate, while readings in Region B are of clinically acceptable accuracy. Readings in C, D and E are inaccurate to various degrees.
Time frame: up to 29 days
Proportion of readings in Region A + Region B of Consensus Error Grid
Analyze the proportion of readings in Region A and Region B.
Time frame: up to 29 days
the percentage of MARD (Mean Absolute Relative Difference)
Analyze the proportion of readings in MARD \<18% (95%CI\<20%).
Time frame: up to 29 days
Alarm success rate1
Hypoglycemia alarm success rate and failure rate (sensitivity)
Time frame: up to 29 days
Alarm success rate2
Hypoglycemia detection rate and missed detection rate (specificity)
Time frame: up to 29 days
Alarm success rate 3
Hyperglycemia alarm success rate and failure rate
Time frame: up to 29 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Alarm success rate 4
Hyperglycemia detection rate and missed detection rate
Time frame: up to 29 days
Sensor Stability
Compare the accuracy of the sensor between Day 2(22h\~48h after insertion), Day 15±1day, Day 29±1day to evaluate sensor.
Time frame: up to 29 days