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Evaluation of the prototype device for glucose monitoring by oral glucose tolerance test

Evaluation of the prototype device for glucose monitoring by oral glucose tolerance test - Evaluation of the prototype device for glucose monitoring by oral glucose tolerance test

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000053471
Enrollment
50
Registered
2024-01-30
Start date
2024-01-30
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

None listed

Interventions

Oral glucose(device) Oral glucose(continuous glucose monitoring) Oral glucose (fingertip sampling) Oral glucose (venous blood collection)

Sponsors

APO PLUS STATION CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Males and females aged 20 years or older at the time of informed consent. 2) Subjects who can make self-judgment and voluntarily gave written informed consent. 3) Subjects whose fasted blood glucose levels are 100 mg/dL or more and less than 126 mg/dL at a health checkup within the past year.

Exclusion criteria

Exclusion criteria: 1)Subjects who are on treatment for a serious illness. 2)Subjects who have been diagnosed with diabetes and under treatment or medication. 3)Subjects who are may develop allergies in connection with the oral glucose tolerance test. 4)Subjects who regularly use licensed drugs or quasi-drugs that may affect the study. 5)Subjects who are currently on treatment at a medical institution for a disease that may affect the study. 6)Subjects who are participating in a clinical trial or have participated in another clinical trial within 1 month before the date of consent for this study. 7)Subjects who are pregnant and those who are breastfeeding. 8)Subjects who plan to participate in another clinical trial during the study period. 9)Subjects who have difficulty in wearing the prototype device. 10)Subjects who have difficulty in wearing continuous glucose monitoring. 11)Subjects who have difficulty in blood drawing from their fingertips by themselves. 12)Subjects who judged as unsuitable for this study by the principal investigator for any reasons.

Design outcomes

Primary

MeasureTime frame
Comparison of glucose level for each of the prototype devices and venous blood sampling, fingertip sampling and continuous glucose monitoring.

Countries

Japan

Contacts

Public ContactMasako Mizuuchi

APO PLUS STATION CO., LTD CRO Business division

food-contact@apoplus.co.jp03-6386-8809

Outcome results

None listed

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