UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033698
Receipt number R000038424
Scientific Title A study on insulin technique of diabetic patients
Date of disclosure of the study information 2018/08/15
Last modified on 2022/08/16 14:08:02

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Basic information

Public title

A study on insulin technique of diabetic patients

Acronym

A study on insulin technique of diabetic patients

Scientific Title

A study on insulin technique of diabetic patients

Scientific Title:Acronym

A study on insulin technique of diabetic patients

Region

Japan


Condition

Condition

diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Extraction of problems of individual insulin techniques and their causes

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

A study on the problem of insulin technique by insulin check sheet which occurs every week or hospitalization and when leaving hospital

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Teaching Insulin techniques

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,Diabetes patients who are hospitalized in our hospital.
2,Diabetes patients who are insulin-treated and self-injected.

Key exclusion criteria

Those who did not agree with this study

Target sample size

50


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

SAKEMI 141-11, OOKAWA city, FUKUOKA

TEL

0944(87)0001

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

SAKEMI 141-11, OOKAWA city, FUKUOKA

TEL

0944(87)0001

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


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

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 07 Month 03 Day

Last follow-up date

2025 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 09 Day

Last modified on

2022 Year 08 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038424


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name