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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000037499
Receipt No. R000042692
Scientific Title Comparative study of two types of insulin injector needle Randomized single-group trial
Date of disclosure of the study information 2019/07/26
Last modified on 2019/08/30

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Basic information
Public title Comparative study of two types of insulin injector needle
Acronym Comparative study of two types of insulin injector needle
Randomized single-group trial
Scientific Title Comparative study of two types of insulin injector needle
Randomized single-group trial
Scientific Title:Acronym Comparison Study of Insulin Pen Needles
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1
BD Micro Fine Pro 32Gx4mm and Nanopass Needle II 34Gx4mm
To compare the usability of a pen-type insulin injector in clinical use.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Taste of needle which we want to use from now on
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The subject uses two types of needles.
Nanopass Needle II 34G x 4 mm -> Micro Fine Pro 32 G x 4 mm
Conduct a questionnaire after use.
Interventions/Control_2 The subject uses two types of needles.
Micro Fine Pro 32G x 4 mm -> Nanopass Needle II 34 G x 4 mm
Conduct a questionnaire after use.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria * Patients with type 1 or 2 diabetes.
* Those who are using a pen-type insulin injector to inject insulin.
* Those who are willing to complete all test procedures.
* Those that can enter the results on the test survey form.
* Those who understand the contents of informed consent and are willing to participate in this exam.
Key exclusion criteria * Pregnancy, or those suspected of it.
* Breastfeeding.
* Those with severe neurological disease.
* Those in physical condition who can not carry out the test procedure (such as patients who can not inject themselves).
* Those judged by the responsible doctor or his / her doctor that there is a risk for participation in this study.
* Patients who have the potential to be confused in the interpretation of test results. Or what I had.
* Employees of pharmaceutical companies or medical equipment companies
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Mizuho
Middle name
Last name Yamabe
Organization Murakami Memorial Hospital
Division name Department of Diabetes Internal medicine
Zip code 722-0014
Address 1-14-26,shinhama,Onomichi-city, Hiroshima,722-0014,Japan
TEL 0848-22-3131
Email mk-hp2@able.ocn.ne.jp

Public contact
Name of contact person
1st name Youko
Middle name
Last name Ochi
Organization Murakami Memorial Hospital
Division name Pharmaceutical department
Zip code 722-0014
Address 1-14-26,shinhama,Onomichi-city, Hiroshima,722-0014,Japan
TEL 0848-22-3131
Homepage URL
Email mkk-pharma@murakami-kinen-hp.jp

Sponsor
Institute Murakami Memorial Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Murakami Memorial Hospital
Address 1-14-26,shinhama,Onomichi-city, Hiroshima,722-0014,Japan
Tel 0848-22-3131
Email mkk-pharma@murakami-kinen-hp.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
2019 Year 07 Month 26 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 Terminated
Date of protocol fixation
2019 Year 07 Month 01 Day
Date of IRB
2019 Year 08 Month 01 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 26 Day
Last modified on
2019 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042692

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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