UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028129 |
|---|---|
| Receipt number | R000032201 |
| Scientific Title | Monitoring of patients with diabetes in a general hospital in Japan: a retrospective observational study |
| Date of disclosure of the study information | 2017/07/07 |
| Last modified on | 2017/11/08 13:54:51 |
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Basic information
Public title
Monitoring of patients with diabetes in a general hospital in Japan: a retrospective observational study
Acronym
Monitoring of patients with diabetes in a general hospital in Japan
Scientific Title
Monitoring of patients with diabetes in a general hospital in Japan: a retrospective observational study
Scientific Title:Acronym
Monitoring of patients with diabetes in a general hospital in Japan
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To monitor clinical courses of patients with diabetes in Department of Diabetes in General Inuyama Chuo Hospital which is a general hospital in Japan.
Basic objectives2
Others
Basic objectives -Others
Observation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dropout rate of outpatients on observation completed
Key secondary outcomes
Continuous rate of outpatients on observation completed
Values of HbA1c and BMI in patients with observation completed on start and finish of observation
Percent complete of HbA1c less than 7% in patients with observation completed on start and finish of observation
Mortality during observation period (infection, total)
Incidence of 3 point mace during observation period
Incidence of admission during observation period (infection, total)
Relationships of HbA1c with mortality and incidence of 3 point mace and admission during observation period (mean, standard deviation and coefficient of variation from start to finish of observation (on events occurrence), on start of observation, on finish of observation (on events occurrence))
Existences of antidiabetic agents usage in patients with observation completed on start and finish of observation
Relationships of antidiabetic agents usage on start and finish of observation with mortality and incidence of 3 point mace and admission during observation period
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
300 patients with diabetes who are visiting Department of Diabetes in General Inuyama Chuo Hospital on June 2016
Key exclusion criteria
Patients who were known not to visit our hospital constantly
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
General Inuyama Chuo Hospital
Division name
Department of Diabetes
Zip code
Address
6, Futagozuka, Goromaru, Inuyama-city, Aichi, 484-8511, Japan.
TEL
0568628111
souichi19811225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
General Inuyama Chuo Hospital
Division name
Department of Diabetes
Zip code
Address
6, Futagozuka, Goromaru, Inuyama-city, Aichi, 484-8511, Japan.
TEL
0568628111
Homepage URL
souichi19811225@yahoo.co.jp
Sponsor or person
Institute
General Inuyama Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2017 | Year | 07 | Month | 07 | 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
| 2017 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe to monitor clinical courses of patients with diabetes who are visiting Department of Diabetes in General Inuyama Chuo Hospital on June 2016 for a year retrospectively.
Management information
Registered date
| 2017 | Year | 07 | Month | 07 | Day |
Last modified on
| 2017 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032201
