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RECRUITING
NCT06796322
NA

Clinical Evaluation of Non-invasive Blood Glucose Meter

Sponsor: Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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.

Official title: A Prospective, Multicenter, Non-randomized, Open-label, Self-controlled, Paired Clinical Trial to Evaluate the Effectiveness and Safety of a Non-invasive Blood Glucose Meter Compared With Laboratory Detection in Diabetic Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2025-01-01

Completion Date

2025-03-31

Last Updated

2025-01-28

Healthy Volunteers

Yes

Interventions

DEVICE

non-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.

DEVICE

fully 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.

DEVICE

fingertip 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.

Locations (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China