UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033700
Receipt number R000038426
Scientific Title A study on blood glucose control after the hospitalization of a diabetic patient
Date of disclosure of the study information 2018/08/15
Last modified on 2023/02/13 08:53:56

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Basic information

Public title

A study on blood glucose control after the hospitalization of a diabetic patient

Acronym

A study on blood glucose control after the hospitalization of a diabetic patient

Scientific Title

A study on blood glucose control after the hospitalization of a diabetic patient

Scientific Title:Acronym

A study on blood glucose control after the hospitalization of a diabetic patient

Region

Japan


Condition

Condition

Diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Studying the factors that worsen blood sugar after the hospitalization of education.

Basic objectives2

Others

Basic objectives -Others

Blood glucose, HbA1c, Glucoalbumin (GA), drugs such as oral and insulin, age, sex, degree of complications, serum insulin, CPR, and education hospitalization due to surgery schedule

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

After discharge, checking the following every few months. Period is five years.

Blood glucose, HbA1c, Glucoalbumin (GA), drugs such as oral and insulin, age, sex, degree of complications, serum insulin, CPR, and education hospitalization due to surgery schedule

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,Diabetic patients who have been hospitalized for diabetes education in Takagi Hospital from January 2008 to December 2017.
2,The people who are able to evaluate the inspection item in a medical record.
3,Diabetic patients who visit Takagi Hospital now.

Key exclusion criteria

The person who did not obtain the consent of the individual

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kenichi
Middle name
Last name Izumi

Organization

Takagi Hospital

Division name

Preventive medicine and Internal medicine

Zip code

831-0016

Address

SAKAMI 141-11, OOKAWA city, FUKUOKA, JAPAN

TEL

0944870001

Email

kenizumi@kouhoukai.org


Public contact

Name of contact person

1st name Kenichi
Middle name
Last name Izumi

Organization

Takagi Hospital

Division name

Preventive medicine and Internal medicine

Zip code

831-0016

Address

SAKAMI 141-11, OOKAWA city, FUKUOKA, JAPAN

TEL

0944870001

Homepage URL


Email

kenizumi@kouhoukai.org


Sponsor or person

Institute

Takagi Hospital

Institute

Department

Personal name



Funding Source

Organization

Takagi Hospital

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

Takagi Hospital IRB

Address

SAKEMI 141-11, OOKAWA city, FUKUOKA, JAPAN

Tel

0944870001

Email

rinri-shinsa@kouhoukai.org


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

2018 Year 08 Month 15 Day


Related information

URL releasing protocol

https://takagi.kouhoukai.or.jp/about/ethics

Publication of results

Unpublished


Result

URL related to results and publications

Unpublishied

Number of participants that the trial has enrolled

35

Results

Unpublishied

Results date posted

2023 Year 02 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients who have been hospitalized in our hospital and have agreed to participate in the study

Participant flow

We explain the research to the patient of our hospital, and obtain a consent form from the person who agrees.

Adverse events

nothing

Outcome measures

HBA1c, blood glucose, DM types, duration of DM, height, weight, CPR, serum insuin, antibody, physical findings on admission, blood biochemical findings

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2018 Year 07 Month 02 Day

Date of IRB

2018 Year 07 Month 02 Day

Anticipated trial start date

2018 Year 08 Month 10 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

In progress


Management information

Registered date

2018 Year 08 Month 09 Day

Last modified on

2023 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038426


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name