UMIN-CTR Clinical Trial

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
Institute	Inuyama Chuo General 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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032205