Diabetes Mellitus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEnon-invasive blood glucose meter
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.
DEVICEfully automatic laboratory biochemical analyzer
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.
DEVICEfingertip capillary blood glucose meter
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.
Sponsors
Shanghai 10th People's Hospital
Hanchuan People's Hospital
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Masking Description
Intervention model description
Glucose detection
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria for healthy subjects: * Male or female, aged \>=18 years. * Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form. Inclusion Criteria for patients with type 2 diabetes: * Male or female, aged \>=18 years. * Previously diagnosed type 2 diabetes according to WHO criteria of 1999. * Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consensus Error Grid (CEG) for venous plasma glucose and glucose values measured by non-invasive glucose meter of mμSORS at each time point indicated. | 3 months | Glucose will be measured using both intravenous sampling (plasma) and non-invasive meter of mμSORS synchronously. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The ±20% agreement were evaluated for non-invasive glucose meter using venous plasma glucose as the control. | 3 months | The interval between the two methods is less than 10 minutes at each point. |
| 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. | 3 months | The interval between the two methods is less than 10 minutes at each point. |
| The regression analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control. | 3 months | The interval between the two methods is less than 10 minutes at each point. |
| The bland-Altman analysis were evaluated for non-invasive glucose meter using venous plasma glucose as the control. | 3 months | The interval between the two methods is less than 10 minutes at each point. |
| The MARD were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control. | 3 months | The interval between the two methods is less than 10 minutes at each point. |
| The MARD were evaluated for non-invasive glucose meter using venous plasma glucose as the control. | 3 months | The interval between the two methods is less than 10 minutes at each point. |
| 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. | 3 months | The interval between the two methods is less than 10 minutes at each point. |
| The regression analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control. | 3 months | The interval between the two methods is less than 10 minutes at each point. |
| The bland-Altman analysis were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control. | 3 months | The interval between the two methods is less than 10 minutes at each point. |
| Incidence of Treatment-Emergent Adverse Events | 3 months | Safety in the patients. |
| The ±20% agreement were evaluated for non-invasive glucose meter using fingertip capillary blood sample as the control. | 3 months | The interval between the two methods is less than 10 minutes at each point. |
Countries
China
Contacts
Primary ContactYifei Zhang, Dr.
Outcome results
None listed