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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033698
Receipt No. R000038424
Scientific Title A study on insulin technique of diabetic patients
Date of disclosure of the study information 2018/08/15
Last modified on 2019/04/16

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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
Institute Takagi Hospital
Institute
Department

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
2021 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
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.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


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