Status:
COMPLETED
To Evaluate the Efficacy and Safety of Multi-parameter Non-Invasive Glucose Sensors for for Blood Glucose Measurement
Lead Sponsor:
Lepu Medical Technology (Beijing) Co., Ltd.
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This was a prospective, multicenter, open-label, self-controlled study to evaluate the efficacy and safety of multi-parameter non-invasive glucose meters for blood glucose measurement，planned enrollme...
Detailed Description
At the same time, blood glucose was measured by non-invasive blood glucose meter, Accu-Chek Guide blood glucose meter and EKF Biosen C-Line. Eight groups of blood glucose values were collected from ea...
Eligibility Criteria
Inclusion
- Subjects with diabetes (type 1 or type 2 );
- Participants who could understand the purpose of the trial and signed the informed consent form.
Exclusion
- Conditions that prevent good contact between the measuring finger and the sensor, resulting in unmeasured conditions, such as hand disability, scar, swelling of the finger, etc.
- Diseases that affect the accuracy of hand measurement, such as Parkinson's disease, upper limb chronic arterial occlusive disease, Raynaud's syndrome, hand or arm trauma surgery, upper limb arteriovenous fistula, etc.
- Fever (axillary temperature \>37.3℃) and severe dehydration during screening;
- Diabetic ketoacidosis, hyperglycemic hyperosmolar status within 6 months before signing the informed consent;
- Those who were in serious illness within 1 month before signing the informed consent, such as shock, heart failure, respiratory failure, severe liver and kidney dysfunction, etc.
- Those suffering from mental illness, lack of self-control or unable to express their personal willingness clearly;
- Participants who participated in other drug or device clinical trials within 2 weeks before signing the informed consent (except those who failed in screening);
- Other persons deemed by the investigator to be ineligible for clinical trial participation.
Key Trial Info
Start Date :
September 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06017349
Start Date
September 21 2022
End Date
July 18 2023
Last Update
August 30 2023
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China