UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042824 |
|---|---|
| Receipt number | R000047728 |
| Scientific Title | Evaluation of glycemic variability with Insulin Aspart (Fiasp) and Insulin Lispro (Lyumjev) for patients with type 1 diabetes mallitus -Prospective observational study- |
| Date of disclosure of the study information | 2020/12/23 |
| Last modified on | 2023/07/24 17:33:53 |
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Basic information
Public title
Evaluation of glycemic variability with Insulin Aspart (Fiasp) and Insulin Lispro (Lyumjev) for patients with type 1 diabetes mallitus -Prospective observational study-
Acronym
Glycemic variability with Insulin Fiasp and Lyumjev for type 1 diabetes
Scientific Title
Evaluation of glycemic variability with Insulin Aspart (Fiasp) and Insulin Lispro (Lyumjev) for patients with type 1 diabetes mallitus -Prospective observational study-
Scientific Title:Acronym
Glycemic variability with Insulin Fiasp and Lyumjev for type 1 diabetes
Region
| Japan |
Condition
Condition
Type 1 diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess glucose variability in patients with type 1 diabetes with continuous subcutaneous insulin infusion therapy with insulin aspart (Fiasp) or insulin lispro (Lyumjev).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Changes in blood glucose variability (including CGM metrics and indicators)
Key secondary outcomes
Relationship between changes in glucose variability and collected data values
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
CSII + CGM or sensor augmented pump are used for insulin infusion device and continuous glucose monitoring.
Insulin aspart (Fiasp) or insulin lispro (Lyumjev) are or scheduled to initiated.
Key exclusion criteria
With pregnancy or lactating
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kyu Yong |
| Middle name | |
| Last name | Cho |
Organization
Hokkaido University Hospital
Division name
Internal Medicine 2, Clinical Research and Medical Innovation Center
Zip code
060-8648
Address
n14w5, kita-ku, Sapporo
TEL
011-706-1161
kyuyong-cho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kyu Yong |
| Middle name | |
| Last name | Cho |
Organization
Hokkaido University Hospital
Division name
Internal Medicine 2, Clinical Research and Medical Innovation Center
Zip code
060-8648
Address
n14w5, kita-ku, Sapporo
TEL
011-706-1161
Homepage URL
kyuyong-cho@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Hokkaido University Hospital for Clinical Research
Address
n15w4, kita-ku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 12 | Month | 23 | Day |
Last modified on
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047728
