UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037933 |
|---|---|
| Receipt number | R000043157 |
| Scientific Title | Comparative study of two types of insulin injector needle Randomized single-group trial |
| Date of disclosure of the study information | 2019/09/05 |
| Last modified on | 2020/03/02 21:34:32 |
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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
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
For patients using Nanopass Needle II 34G x 4 mm
Use BD Micro Fine Pro 32G x 4 mm 5 times,
Conduct a questionnaire after use.
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
| 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
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
mkk-pharma@murakami-kinen-hp.jp
Sponsor or person
Institute
Murakami Memorial Hospital
Institute
Department
Personal name
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
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 | 09 | Month | 05 | 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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | 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 | 09 | Month | 05 | Day |
Last modified on
| 2020 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043157
