Diabetes mellitus
Conditions
Interventions
Gold Standard:Invasive fingertip blood glucose as the gold standard
Index test:Non-invasive blood glucose monitoring equipment
Sponsors
Beijing Physical Examination Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diabetic patients: according to the diagnostic criteria of diabetes mellitus, patients with type 2 diabetes mellitus diagnosed by endocrinologists; or taking diabetes medication; or fasting venous glucose of not less than 7.0 mmol/L; or random glucose of not less than 11.1 mmol/L; or 2-hour glucose of not less than 11.1 mmol/L in the oral glucose tolerance test (OGTT); or glycosylated haemoglobin of more than 6%; and informed consent to participate voluntarily. Haemoglobin greater than 6.5%; and informed consent and voluntary participation 2. Pre-diabetes: fasting venous blood glucose between 6.1~6.9mmol/L; and oral glucose tolerance test (OGTT) 2-hour blood glucose between 7.8~11.0mmol/L; or glycated haemoglobin between 5.7~6.4%; and informed consent, voluntary participation 3. Normal population: Normal physical examination population, in line with the principle of informed consent and voluntary participation
Exclusion criteria
Exclusion criteria: Patients with primary psychiatric disorders with limited language communication; patients with surgery or history of major trauma in the previous 3 months; patients with severe acute illnesses such as dehydration and shock; patients with abnormalities of glucose metabolism, high blood lipids (TC>600mg/dl, TG>750mg/dl), and elevated bilirubin (total bilirubin>20mg/dl); and patients with a place of residence other than Beijing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 20/20% concordance of the reference value;Proportion of measurement points falling in A+B zone of Clarke error raster analysis;Proportion of measurement points falling in the A+B zone of the Consensus error raster analysis;Mean Absolute Relative Error Value (MARD%); | — |
Countries
China
Contacts
Public ContactGuo Xiuhua
Capital Medical University
Outcome results
None listed