UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018263 |
|---|---|
| Receipt number | R000021135 |
| Scientific Title | Which Japanese patients with type 1 diabetes would benefit from continuous subcutaneous insulin infusion? |
| Date of disclosure of the study information | 2015/07/09 |
| Last modified on | 2015/07/09 23:31:00 |
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Basic information
Public title
Which Japanese patients with type 1 diabetes would benefit from continuous subcutaneous insulin infusion?
Acronym
Which Japanese patients with type 1 diabetes would benefit from continuous subcutaneous insulin infusion?
Scientific Title
Which Japanese patients with type 1 diabetes would benefit from continuous subcutaneous insulin infusion?
Scientific Title:Acronym
Which Japanese patients with type 1 diabetes would benefit from continuous subcutaneous insulin infusion?
Region
| Japan |
Condition
Condition
Endocrinology and Metabolism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We attempted to determine which Japanese patients with T1D were appropriate candidates for continuous subcutaneous insulin infusion (CSII).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 1 diabetic patients provided written informed consent to participate in the study,and treated with CSII
Key exclusion criteria
severe visual impairment, hearing disturbance, and those who could not perform self-monitoring of blood glucose at least four times per day.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Taki |
Organization
The Jikei university school of medicine
Division name
Diabetes,metabolism and endocrinology
Zip code
Address
3-25-8,nishi-shinbashi,minato-ku,Tokyo,japan
TEL
03-3433-1111
tackey@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Taki |
Organization
The Jikei university school of medicine
Division name
Diabetes,metabolism and endocrinology
Zip code
Address
3-25-8,nishishinbashi,minato-ku,tokyo
TEL
03-3433-1111
Homepage URL
tackey@jikei.ac.jp
Sponsor or person
Institute
The jikei university school of medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine, Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 07 | Month | 09 | 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
| 2005 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We compared the CSII effective group to the CSII ineffective group.
Management information
Registered date
| 2015 | Year | 07 | Month | 09 | Day |
Last modified on
| 2015 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021135
