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New treatment option for Diabetes Mellitus
Official title Clinical Evaluation of Non-invasive Blood Glucose Meter
ClinicalTrials.gov ID: NCT06796322
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- for healthy people:
- Male or female, aged \>=18 years.
- Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand...
- Male or female, aged \>=18 years.
- Previously diagnosed type 2 diabetes according to WHO criteria of 1999.
You likely can't join if
- Exclusion Criteria for healthy people:
- There are injuries, scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested.
- 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).
See the full eligibility criteria
- for healthy people:
- Male or female, aged \>=18 years.
- 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...
- 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...
- Exclusion Criteria for healthy people:
- There are injuries, scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested.
- 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. Exclusion Criteria for patients with type 2 diabetes:
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.