UMIN ID: UMIN000054275
Registered date:02/05/2024
Observational Study of the Relationship between the Use of Real-time Continuous Glucose Monitoring and the Glycemic Control in Patients with Diabetes in Japan
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Diabetes |
| Date of first enrollment | 2024/05/30 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Change in HbA1c from baseline to 26 weeks after use of Dexcom G6 Change in TIR (pre, 0week, 26week) Change in TBR (pre, 0week, 26week) Change in TAR (pre, 0week, 26week) Change in glycemia risk index (GRI)(pre, 0week, 26week) Average glucose levels(pre, 0week, 26week) Change in glucose management indicator (GMI) (pre, 0week, 26week) Change in CV(pre, 0week, 26week) Change in CGM active time(pre, 0week, 26week) |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | A history of real-time CGM use within 12 weeks of Dexcom G6 use pregnancy |
Related Information
| Primary Sponsor | Tokai University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Dexcom Inc. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masao Toyoda |
| Address | 143, Shimokasuya, Isehara, Kanagawa, JAPAN Japan 259-1193 |
| Telephone | 0463-93-1121 |
| m-toyoda@tokai.ac.jp | |
| Affiliation | Tokai University School of Medicine Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, |
| scientific contact | |
| Name | Masao Toyoda |
| Address | 143, Shimokasuya, Isehara, Kanagawa, JAPAN Japan |
| Telephone | 0463-93-1121 |
| m-toyoda@tokai.ac.jp | |
| Affiliation | Tokai University School of Medicine Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, |