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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028131
Receipt No. R000032205
Scientific Title Monitoring of patients with diabetes in a general hospital in Japan: a prospective observational study
Date of disclosure of the study information 2017/07/07
Last modified on 2017/09/04

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Basic information
Public title Monitoring of patients with diabetes in a general hospital in Japan: a prospective 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 prospective 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, BMI and CPI in patients with observation completed on start and finish of observation
Percent complete of HbA1c less than 7.0% 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)
Relationships of BMI with mortality and incidence of 3 point mace and admission during observation period (on start of observation and on finish of observation (on events occurrence))
Relationships of CPI with mortality and incidence of 3 point mace and admission during observation period (on start of observation and on finish of observation (on events occurrence))
Relationships of duration of diabetes with mortality and incidence of 3 point mace and admission during observation period
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 500 patients with diabetes who are visiting Department of Diabetes in General Inuyama Chuo Hospital on July 2017
Key exclusion criteria Patients who were known not to visit our hospital constantly
Target sample size 500

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
Email 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
Email souichi19811225@yahoo.co.jp

Sponsor
Institute General Inuyama Chuo Hospital
Institute
Department

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
Email

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 Open public recruiting
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 To monitor clinical courses of patients with diabetes in Department of Diabetes in General Inuyama Chuo Hospital which is defined as a massive general hospital in Japan.

Management information
Registered date
2017 Year 07 Month 07 Day
Last modified on
2017 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032205

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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