UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015648
Receipt number R000018165
Scientific Title Survey of medical management, patient education and complications in diabetes
Date of disclosure of the study information 2014/11/10
Last modified on 2018/05/15 23:05:33

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Basic information

Public title

Survey of medical management, patient education and complications in diabetes

Acronym

Survey of medical care in diabetes

Scientific Title

Survey of medical management, patient education and complications in diabetes

Scientific Title:Acronym

Survey of medical care in diabetes

Region

Japan


Condition

Condition

Diabetes mellitus

Classification by specialty

Endocrinology and Metabolism Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To comprehensively examine the factors related to glycemic control and diabetic complications.

Basic objectives2

Others

Basic objectives -Others

Observational epidemiological study

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.Glycemic control
2.Frequency of hypoglycemia
3.Onset and progress of diabetic complications

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Outpatients with diabetes
2.Obtained written consent

Key exclusion criteria

1.Subjects who have difficulty with comprehension, psychiatric disease or procedural problems

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuya Inagaki

Organization

Graduate School of Medicine, Kyoto Univesity

Division name

Department of Diabetes, Endocrinology and Nutrition

Zip code


Address

Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto-city, Kyoto, Japan

TEL

075-751-3560

Email

inagaki@metab.kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akiko Nishimura

Organization

Graduate School of Medicine, Kyoto Univesity

Division name

Department of Human Health Science

Zip code


Address

Shogoin Kawahara-cho 53, Sakyo-ku, Kyoto-city, Kyoto, Japan

TEL

075-751-3927

Homepage URL


Email

nishimura.akiko.3z@kyoto-u.ac.jp


Sponsor or person

Institute

Graduate School of Medicine, Kyoto Univesity

Institute

Department

Personal name



Funding Source

Organization

Kyoto University

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

2014 Year 11 Month 10 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

2014 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 11 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective observational study using basal insulin injection time, self-reported questionnaires, and medical examination.


Management information

Registered date

2014 Year 11 Month 10 Day

Last modified on

2018 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018165


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name