UMIN ID: UMIN000025952
Registered date:01/02/2017
Which is the best long-acting insulin to reduce hypoclycemia ? Comparison of Insulin glargine 300 U/ml vs. Insulin degludec vs. Insulin glargine 100 U/ml using FreeStyle Libre Pro: randomised triple crossover study
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | diabetes |
| Date of first enrollment | 2017/02/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | FreeStyle Libre Pro is worn after admission. Insulin glargine 300 U/ml are evaluated on day 3 and day 4. Then, Insulin degludec are evaluated on day 8 and day 9. Then, Insulin glargine 100 U/ml are evaluated on day 13 and day 14. FreeStyle Libre Pro is worn after admission. Insulin degludec are evaluated on day 3 and day 4. Then, Insulin glargine 100 U/ml are evaluated on day 8 and day 9. Then, Insulin glargine 300 U/ml are evaluated on day 13 and day 14. FreeStyle Libre Pro is worn after admission. Insulin glargine 100 U/ml are evaluated on day 3 and day 4. Then, Insulin glargine 300 U/ml are evaluated on day 8 and day 9. Then, Insulin degludec are evaluated on day 13 and day 14. |
Outcome(s)
| Primary Outcome | AOC (<70 mg/dL) for glycemic variability (0:00-6:00, 8:00-24:00, 24:00) |
|---|---|
| Secondary Outcome | 00:00 to 6:00 percentage of time in hypoglycemic range (<54 mg/dL) mean absolute glucose (MAG) glycemic variability percentage (GVP) mean glucose level (0:00-6:00, 24:00) SD (0:00-6:00, 24:00) coefficient of variation (CV) (0:00-6:00, 24:00) M-value (0:00-6:00, 24:00) MAGE MODD ADRR low blood glucose index (LBGI) |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 90years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | severe renal dysfunction (serum creatinine level over 2.0 mg/dL) judged to be unsuitable for participation for medical reasons |
Related Information
| Primary Sponsor | General Inuyamachuo Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | General Inuyamachuo Hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Soichi Takeishi |
| Address | 6, futakozuka, goroumaru, Inuyama-city, Aichi, 484-8511, Japan. Japan |
| Telephone | 0568-62-8111 |
| souichi19811225@yahoo.co.jp | |
| Affiliation | General Inuyamachuo Hospital Department of Diabetes |
| scientific contact | |
| Name | Soichi Takeishi |
| Address | 6, futakozuka, goroumaru, Inuyama-city, Aichi, 484-8511, Japan. Japan |
| Telephone | 0568-62-8111 |
| souichi19811225@yahoo.co.jp | |
| Affiliation | General Inuyamachuo Hospital Department of Diabetes |