This trial is a prospective, multicenter, non-randomized, open-label, self-controlled, paired design clinical study, which will be conducted in 3 research centers, with a total of 210 subjects enrolled, including diabetic patients aged 18 years and above and some healthy subjects. After screening, each eligible subject will have their blood glucose measured simultaneously at specified time points using three methods: non-invasive blood glucose meter (the experimental group), fully automatic laboratory biochemical analyzer (the primary control group) using the hexokinase method to measure venous plasma blood glucose, and fingertip capillary blood sample (the secondary control group) to detect fingertip capillary blood glucose. The aim of this trial is to evaluate the efficacy and safety of the non-invasive blood glucose meter for blood glucose measurement in diabetic patients.
After screening, the qualified subjects complete the blood glucose measurement in three ways at the following time points on the test day, namely, fasting blood glucose before breakfast, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
210
Blood glucose were detected by non-invasive glucose meter at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast.
Blood glucose were detected by fully automatic laboratory biochemical analyzer using plasma sample at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast.
Blood glucose were detected by fingertip capillary blood sample at four time points, namely fasting, 1 hour post breakfast, 2 hours post breakfast, and 3 hours post breakfast.
Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGConsensus Error Grid (CEG) for venous plasma glucose and glucose values measured by non-invasive glucose meter of mμSORS at each time point indicated.
Glucose will be measured using both intravenous sampling (plasma) and non-invasive meter of mμSORS synchronously.
Time frame: 3 months
The MARD were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
The interval between the two methods is less than 10 minutes at each point.
Time frame: 3 months
The ±20% agreement were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
The interval between the two methods is less than 10 minutes at each point.
Time frame: 3 months
The point proportion of A+B region of Clarke error grid analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
The interval between the two methods is less than 10 minutes at each point.
Time frame: 3 months
The regression analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
The interval between the two methods is less than 10 minutes at each point.
Time frame: 3 months
The bland-Altman analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control.
The interval between the two methods is less than 10 minutes at each point.
Time frame: 3 months
The MARD were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
The interval between the two methods is less than 10 minutes at each point.
Time frame: 3 months
The ±20% agreement were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
The interval between the two methods is less than 10 minutes at each point.
Time frame: 3 months
The point proportion of A+B region of Clarke error grid analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
The interval between the two methods is less than 10 minutes at each point.
Time frame: 3 months
The regression analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
The interval between the two methods is less than 10 minutes at each point.
Time frame: 3 months
The bland-Altman analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control.
The interval between the two methods is less than 10 minutes at each point.
Time frame: 3 months
Incidence of Treatment-Emergent Adverse Events
Safety in the patients.
Time frame: 3 months
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