UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028131
Receipt number 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 2022/11/18 09:19:52

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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 Soichi
Middle name
Last name Takeishi

Organization

Inuyama Chuo General Hospital

Division name

Department of Diabetes

Zip code

484-8511

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 Soichi
Middle name
Last name Takeishi

Organization

Inuyama Chuo General Hospital

Division name

Department of Diabetes

Zip code

484-8511

Address

6, Futagozuka, Goromaru, Inuyama-city, Aichi, 484-8511, Japan.

TEL

0568628111

Homepage URL


Email

souichi19811225@yahoo.co.jp


Sponsor or person

Institute

Inuyama Chuo General 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

Inuyama Chuo General Hospital

Address

6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.

Tel

0568-62-8111

Email

souichi19811225@yahoo.co.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

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

500

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

Terminated

Date of protocol fixation

2017 Year 07 Month 07 Day

Date of IRB

2017 Year 07 Month 25 Day

Anticipated trial start date

2017 Year 07 Month 25 Day

Last follow-up date

2035 Year 12 Month 31 Day

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

2022 Year 11 Month 18 Day



Link to view the page

Value
https://center6.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