Validation of non-invasive blood glucose measurement

JRCT ID: jRCTs032220521

Registered date:19/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetes (Type 1,2)
• Date of first enrollment: 19/12/2022
• Target sample size: 410
• Study type: Interventional

Intervention(s)

[Measurement A]
Before and after a meal, perform non-invasive blood glucose measurement using the test device after blood glucose measurement using the invasive method, and again 10 to 15 minutes later. As a rule, this is performed every hour for a maximum of 7 times per day.
[Measurement B]
After a meal, minimally invasive blood glucose measurement is followed by non-invasive blood glucose measurement using the test device. This is performed every 10 minutes for a maximum of 15 times per day.

Outcome(s)

• Primary Outcome: Difference between blood glucose level in venous blood and blood glucose level estimated from test equipment
• Secondary Outcome: Difference between the range of change in venous blood glucose or SMBG and CGM measurements and the range of change in blood glucose estimated from non-invasive devices, and the number of successful measurements/number of measurements of blood glucose estimated from non-invasive devices

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Inpatients who meet all of the following selection criteria will be eligible for the study and whose consent has been obtained
1.Patients who are able to have at least 5 blood samples taken and blood glucose level measured by the test device.
2. Age Patients who are at least 18 years old at the time consent is obtained.
3. Gender Any gender
4. Patients who have been fully informed of the study and who have given written consent of their own free will.
5. Patients who possess SMBG equipment (SMBG capable of acquiring data up to 15 times every 10 minutes) or wear CGM equipment (FreestyleLibre) (Measurement B only)

Exclude criteria

Patients who meet at least one of the following exclusion criteria will be excluded.
(1) Patients who require immediate treatment due to changes in blood glucose levels
(2) Patients who are judged by the principal investigator (subinvestigator) to be inappropriate to participate in this study.

Related Information

• Primary Sponsor: Nishimura Rimei
• Secondary Sponsor: Akiyama Koichi,Mitsubishi Electric Corporation