UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053425 |
|---|---|
| Receipt number | R000060622 |
| Scientific Title | Examination of the Frequency and Risk Factors of Insulin Therapy-Related Indurations |
| Date of disclosure of the study information | 2024/01/24 |
| Last modified on | 2024/01/24 12:07:21 |
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Basic information
Public title
Examination of the Frequency and Risk Factors of Insulin Therapy-Related Indurations
Acronym
Examination of the Frequency and Risk Factors of Insulin Therapy-Related Indurations
Scientific Title
Examination of the Frequency and Risk Factors of Insulin Therapy-Related Indurations
Scientific Title:Acronym
CSII-LH study
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the frequency and risk factors of indurations in individuals with type 1 diabetes using insulin pumps, comparing them with those who do not use pumps. Indurations resulting from insulin therapy can diminish the effectiveness of insulin injections. By revealing the frequency and risk factors associated with indurations, there is a potential to enhance the efficiency of diabetes treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The objective of this study is to elucidate the frequency and risk factors associated with indurations in individuals with type 1 diabetes using insulin pumps, in comparison with those who do not use pumps.
Key secondary outcomes
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
| 4 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Age 4 and above
2)Type 1 diabetes
Key exclusion criteria
1)Not undergoing insulin therapy (CSII or MDI)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Seiko |
| Middle name | |
| Last name | Sakane |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Preventive Medicine, Clinical Research Institute
Zip code
6112-8555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto
TEL
075-641-9161
404-j-doit1@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Sakane |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Preventive Medicine, Clinical Research Institute
Zip code
612-8555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto
TEL
075-641-9161
Homepage URL
404-j-doit1@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan.
Tel
075-641-9161
404-j-doit1@mail.hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Survey Research, Cross-Sectional Study, Observational Study
Management information
Registered date
| 2024 | Year | 01 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060622
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
