Skip to content

A Prospective Interventional Study to Estimate Glucose Tolerance Using Continuous Glucose Monitoring

A Prospective Interventional Study to Estimate Glucose Tolerance Using Continuous Glucose Monitoring - A Prospective Interventional Study to Estimate Glucose Tolerance Using Continuous Glucose Monitoring

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056752
Enrollment
68
Registered
2025-01-18
Start date
2025-04-01
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

Non-diabetes

Interventions

Performing a 75gOGTT and glucose clamp test on non-diabetic individuals. Equip non-diabetic individuals with continuous glucose monitoring devices. Provide non-diabetic individuals with simple carbohy

Sponsors

Kobe university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Individuals who have not been diagnosed with diabetes or who, despite a prior diagnosis, are not undergoing pharmacological treatment. (2) Individuals aged 20 years or older. (3) Individuals who have provided written informed consent to participate in this clinical study voluntarily.

Exclusion criteria

Exclusion criteria: (1) Individuals with a history of gastrointestinal surgery that could affect blood glucose changes or glucose tolerance (total gastrectomy, total colectomy, or bariatric surgery are excluded; endoscopic treatments and appendectomy are not excluded). (2) Individuals with any skin condition (blisters, redness, swelling, rash, bleeding, infection, or purpura) at the CGM attachment site, such as the upper arm or abdomen. (3) Individuals with a known history of hypersensitivity to the study drug. (4) Individuals using medications that affect glucose metabolism (steroid preparations or beta-blockers). (5) Individuals diagnosed within the past year with severe renal impairment ((eGFR 30 mL/min/1.73 m2 or less at the start of the study). (6) Individuals diagnosed within the past year with severe cardiac disease (NYHA class III or higher). (7) Individuals with coagulation disorders. (8) Pregnant or potentially pregnant individuals, or those who are breastfeeding. (9) Individuals undergoing treatment for malignant diseases. (10) Individuals with psychiatric disorders or those lacking sufficient decision-making capacity to cooperate with the study. (11) Individuals with endocrine disorders that could affect glucose tolerance (hyperthyroidism, pheochromocytoma). (12) Any other individuals deemed inappropriate for participation by the investigator.

Design outcomes

Primary

MeasureTime frame
Verify the validity of the parameter K estimated using the mathematical model F = KG to assess glucose tolerance based on continuous glucose monitoring.

Secondary

MeasureTime frame
The correlation between the glucose tolerance index K, estimated from glucose waveforms obtained through continuous glucose monitoring, and the glucose tolerance index calculated from the glucose clamp test.

Countries

Japan

Contacts

Public ContactKazuhiko Sakaguchi

Kobe university Department of Diabetes and Endocrinology

kzhkskgc@med.kobe-u.ac.jp078-382-5861

Outcome results

None listed

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