Clinical Evaluation of Non-invasive Blood Glucose Meter
NCT ID: NCT06796322
Last Updated: 2025-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
210 participants
INTERVENTIONAL
2025-01-01
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Non-invasive blood glucose meter
Non-invasive blood glucose meter by the non-invasive blood glucose meter using a Raman spectrum measurement system.
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.
Fully automatic laboratory biochemical analyzer
Fully automatic laboratory biochemical analyzer (the primary control group) using the hexokinase method to measure venous plasma blood glucose.
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.
Fingertip capillary blood sample
Fingertip capillary blood sample (the secondary control group) to detect fingertip capillary blood glucose.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form.
* Male or female, aged \>=18 years.
* Previously diagnosed type 2 diabetes according to WHO criteria of 1999.
* Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form.
Exclusion Criteria
* Allergy to lasers.
* Had diabetes history or fasting blood glucose (FPG) \>= 6.1 mmol/L or glycated hemoglobin (HbA1c) \>= 5.7% during the screening period.
* Alcohol dependency or drug abuse.
* Those who have participated in clinical trials of other drugs within 3 months before screening (since the last visit of the previous trial).
* Pregnancy or lactation period.
* Difficulty in venous blood collection or fainting of needles or blood.
* Other circumstances that the investigator considers inappropriate to participate in the study.
* There are injuries, scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested.
* Allergy to lasers.
* Type 1 diabetes, monogenic mutant diabetes, pancreatic damage, or secondary diabetes of other causes should be excluded.
* Severe structural heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, chronic congestive heart failure (NYHA≥III); acute myocardial infarction within 12 months before enrollment; history of severe liver or kidney dysfunction (eGFR \< 60 ml/min/1.73m2 calculated by MDRD formula at screening period); and mental disorders, etc.
* With a history of acute complications of diabetes within 3 months before enrollment; or severe diabetes-related complications.
* Alcohol dependency or drug abuse.
* Those who have participated in clinical trials of other drugs within 3 months before screening (since the last visit of the previous trial).
* Pregnancy or lactation period.
* Difficulty in venous blood collection or fainting of needles or blood.
* Other circumstances that the investigator considers inappropriate to participate in the study.
18 Years
ALL
Yes
Sponsors
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Shanghai 10th People's Hospital
OTHER
Hanchuan People's Hospital
UNKNOWN
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Wang Weiqing
Professor
Principal Investigators
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Weiqing Wang, Dr.
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JGKJ01202401
Identifier Type: -
Identifier Source: org_study_id
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