Actively Recruiting
Clinical Evaluation of Non-invasive Blood Glucose Meter
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2025-01-28
210
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiao Tong University School of Medicine
Lead Sponsor
S
Shanghai 10th People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Evaluation of Non-invasive Blood Glucose Meter
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 years or older
- Understand the study and willing to complete the entire process with written consent
- For patients: previously diagnosed type 2 diabetes according to WHO 1999 criteria
- For healthy subjects: no diabetes diagnosis and meet other health criteria
You will not qualify if you...
- Injuries, scars, or pigmentation on palm interfering with measurement
- Allergy to lasers
- For healthy subjects: diabetes history, fasting blood glucose ≥ 6.1 mmol/L, or HbA1c ≥ 5.7% during screening
- Alcohol dependency or drug abuse
- Participation in other clinical drug trials within 3 months before screening
- Pregnancy or lactation
- Difficulty with venous blood collection or needle fainting
- For patients: type 1 diabetes, monogenic mutant diabetes, pancreatic damage, or secondary diabetes
- Severe heart disease, recent myocardial infarction, severe liver or kidney dysfunction, mental disorders
- Recent acute or severe diabetes complications
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
Y
Yifei Zhang, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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