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Validation of non-invasive blood glucose measurement

A validative clinical study comparing non-invasive blood glucose measurement by mid-infrared spectroscopy and venous blood glucose in diabetic patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032220521
Enrollment
410
Registered
2022-12-19
Start date
2022-12-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes (Type 1,2) Diabetes

Interventions

[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 late

Sponsors

Nishimura Rimei
Lead Sponsor
Akiyama Koichi
Collaborator
Mitsubishi Electric Corporation
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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)

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Difference between blood glucose level in venous blood and blood glucose level estimated from test equipment

Secondary

MeasureTime frame
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

Contacts

Public ContactRimei Nishimura

The Jikei University Hospital

rimei.nishimura@gmail.com+81-3-3433-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026