Impaired glucose tolerance, diabetes mellitus
Conditions
Interventions
Gold Standard:Serum ketone levels measured by laboratory methods
Index test:Subcutaneous implantable continuous tissue ketone monitoring device
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. According to the WHO 2019 classification criteria for glucose metabolism, patients with normal glucose metabolism, abnormal glucose regulation, and diabetic patients diagnosed with OGTT; 2. Subjects aged 18 to 80 years, male and female subjects (including 18 and 80 years old); 3.BMI>=24Kg/m^2; 4. Agree to participate in this study and sign the Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: 1. Patients with unstably controlled severe cardiovascular disease, hepatic or renal dysfunction, or a combination of uncontrolled severe ketoacidosis, or the presence of a serious infection; 2. Patients who are not readily cooperative, have psychiatric disorders that interfere with informed consent and/or AE presentation or observation; 3. Subjects with blood triglycerides > 500 mg/dL or > 5.7 mmol/L (based on CTCAE version 5.0) 4. Subjects with blood cholesterol > 400 mg/dL or > 10.34 mmol/L (based on CTCAE version 5.0); 5. Female subjects who are breastfeeding or have a positive pregnancy test result at the time of the Screening Examination; 6. Subjects who have participated in another clinical trial within 1 month prior to the Screening Examination; 7. Those who are considered by the investigator to be inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ketone (serum, capillary, tissue);serum c peptide; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucose (plasma, capillary, tissue);serum insulin;Biochemistry (liver and kidney function);HbA1c; | — |
Countries
China
Contacts
Public ContactLi Ang
Peking University First Hospital
Outcome results
None listed