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The Accuracy and Stability of Noninvasive Blood Glucose Meter Based on Metabolic Heat Integration in Short-term Repeat Detection of Diabetic Patients

The Accuracy and Stability of Noninvasive Blood Glucose Meter Based on Metabolic Heat Integration in Short-term Repeat Detection of Diabetic Patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900028100
Enrollment
Unknown
Registered
2019-12-11
Start date
2019-12-12
Completion date
Unknown
Last updated
2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

Gold Standard:Fingertip capillary blood glucose test
Blood&#32

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Agree to participate in this study and sign an informed consent form (ICF); 2. Aged 18 to 75 years, male and female subjects; 3. The subjects with diabetes treated by Peking University First Hospital.

Exclusion criteria

Exclusion criteria: 1. Donated blood or lost blood for more than 400 mL within 30 days before screening test; 2. Have received vasoconstrictor drugs, dopamine, procaine, lidocaine, butzocaine and other drugs within 7 days before the screening test; 3. Drugs or diseases that affect the test results within 7 days before the screening test, such as the use of diluted drugs (such as US blue, indigo green, acid indigo) or carbon monoxide or methionine or thiohemoglobin in the body 4. Diseases with severe impact on the results of the study, such as severe cardiovascular disease, liver and kidney dysfunction, or patients with severe ketoacidosis and severe infection; 5. Currently have diseases that affect the accuracy of hand measurement: such as Parkinson's history, chronic arterial occlusion, hand or arm trauma surgery, arteriovenous fistula, etc.; 6. Patients who have difficulty cooperating, have mental illness, affect informed consent and / or AE presentation or observation; 7. Hematocrit > 55% of subjects; 8. Subjects with TSH >10 uIU/mL or 3.0 times the upper limit of normal value 10. Subjects with blood triglycerides > 500 mg/dL or > 5.7 mmol/L; 11. Subjects with blood cholesterol >400 mg/dL or >10.34 mmol/L; 12. Female subjects who are breastfeeding or have a positive pregnancy test at the time of screening; 13. Participants in other clinical trials within 1 month before the screening test; 14. Investigators consider it inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
SEN, SPE, ACC, AUC of ROC;Coefficient of variation;Glucose concentration in tissue fluid;

Countries

China

Contacts

Public ContactJunqing Zhang

Peking University First Hospital

junqing.zhang@pkufh.cn+86 13611167278

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026