UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007259 |
|---|---|
| Receipt number | R000008104 |
| Scientific Title | Establishment of the new blood glucose management for diabetes mellitus patients by next generation artificial pancreas |
| Date of disclosure of the study information | 2012/02/20 |
| Last modified on | 2018/08/30 11:59:24 |
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Basic information
Public title
Establishment of the new blood glucose management for diabetes mellitus patients by next generation artificial pancreas
Acronym
The new blood glucose management for diabetes mellitus patients by next generation artificial pancreas
Scientific Title
Establishment of the new blood glucose management for diabetes mellitus patients by next generation artificial pancreas
Scientific Title:Acronym
The new blood glucose management for diabetes mellitus patients by next generation artificial pancreas
Region
| Japan |
Condition
Condition
Patients with diabetes mellitus who are going to be undergone digestive surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the optimal concentration of perioperative glycemic control effective to prevent postoperative infectious complications in patients with diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Surgical site infection (SSI)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group A (Targeted blood glucose range is from 80 to 110 mg/dl)
Interventions/Control_2
Group B (Targeted blood glucose range is from 110 to 140 mg/dl)
Interventions/Control_3
Group C (Targeted blood glucose range is from 140 to 180 mg/dl)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with diabetes mellitus who are going to be undergone digestive surgery
Key exclusion criteria
none
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Hanazaki |
Organization
Kochi Medical School
Division name
Department of Surgery 1
Zip code
Address
Kohasu, Okocho, Nankoku, Kochi
TEL
088-880-2370
im-31@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kitagawa |
Organization
Kochi Medical School
Division name
Department of Surgery 1
Zip code
Address
Kohasu, Okocho, Nankoku, Kochi
TEL
088-880-2370
Homepage URL
kitagawah@kochi-u.ac.jp
Sponsor or person
Institute
Department of Surgery 1, Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 02 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | 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
Management information
Registered date
| 2012 | Year | 02 | Month | 10 | Day |
Last modified on
| 2018 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008104
| 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 |
