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Clinical trial of performance evaluation of glucose meter

Clinical trial of performance evaluation of Happy -100 noninvasive combined glucose meter

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043819
Enrollment
Unknown
Registered
2021-03-04
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-07-05

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

Conditions

Type 2 diabetes

Interventions

Test equipment:Measure your blood glucose
Control equipment:Measure your blood glucose

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects whose oral temperature can be measured; 2. Subjects over 18 years old; 3. Subjects with type 2 diabetes (see Appendix) were diagnosed according to WHO1999 criteria. 4. The subjects who agreed to participate in the clinical study and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who refused to collect venous blood during the trial; 2. Patients with fever (axillary temperature >= 37.3 degrees C) or symptoms of vomiting, diarrhea (defecation frequency >= 4 times / day), syncope and dehydration were screened; 3. Patients in pregnancy or lactation period; 4. Patients with intravenous infusion planned during the trial period; 5. Patients who plan to adjust hypoglycemic treatment during the trial; 6. Patients with mental illness, lack of self-control or unable to express their wishes clearly; 7. Patients considered unsuitable by the researchers; 8. Patients who participated in other clinical trials in the past month.

Design outcomes

Primary

MeasureTime frame
Accuracy of noninvasive glucose measurement;Product ease-of-use evaluation;

Secondary

MeasureTime frame
Accuracy of invasive glucose measurement;

Countries

China

Contacts

Public ContactJi Linong
jiln@bjmu.edu.cn+86 10-88326666

Outcome results

None listed

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