Evaluation of a non-invasive blood glucose meter for diabetes management

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

This study is testing a new non-invasive blood glucose meter to see if it works well for people with diabetes compared to traditional methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06796322 on ClinicalTrials.gov

What this trial studies

This clinical evaluation involves a multicenter, non-randomized, open-label design to assess the efficacy and safety of a non-invasive blood glucose meter in diabetic patients. A total of 210 subjects, including both diabetic patients and healthy individuals, will participate in the study. Blood glucose levels will be measured simultaneously using the non-invasive meter, a fully automatic laboratory analyzer, and a fingertip capillary blood glucose meter at various time points throughout the day. The goal is to determine how well the non-invasive method performs compared to traditional blood glucose measurement techniques.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and above with a diagnosis of type 2 diabetes.

Not a fit: Patients with conditions that affect skin integrity or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more convenient and less invasive method for blood glucose monitoring in diabetic patients.

How similar studies have performed: Other studies have explored non-invasive glucose monitoring methods, but the success of this specific approach remains to be determined.

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria for healthy subjects:

* 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 process, and provide written consent form.

Inclusion Criteria for patients with type 2 diabetes:

* 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:

Exclusion Criteria for healthy subjects:

* 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 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.

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Weiqing Wang, Dr. — Ruijin Hospital
• Study coordinator: Yifei Zhang, Dr.

Conditions Diabetes Mellitus