Non-diabetes
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Kobe university Department of Diabetes and Endocrinology