UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023673 |
|---|---|
| Receipt number | R000027255 |
| Scientific Title | Comparison of effects of BD Micro Fine Plus and NANOPASS Needle II in diabetic patients with insulin therapy |
| Date of disclosure of the study information | 2016/08/19 |
| Last modified on | 2019/02/20 10:27:53 |
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Basic information
Public title
Comparison of effects of BD Micro Fine Plus and NANOPASS Needle II in diabetic patients with insulin therapy
Acronym
Comparison of effects of 32G 4mm and 34G 4mm insulin pen needle in diabetic patients with insulin therapy
Scientific Title
Comparison of effects of BD Micro Fine Plus and NANOPASS Needle II in diabetic patients with insulin therapy
Scientific Title:Acronym
Comparison of effects of 32G 4mm and 34G 4mm insulin pen needle in diabetic patients with insulin therapy
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the puncture site pain between 32G 4mm needle (BD Micro Fine Plus) and 34G 4mm needle (NANOPASS Needle II).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of puncture site pain using the visual analogue scale
Key secondary outcomes
HbA1c, Adverse events (dribbling, bleeding, needle breakage)
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
| Device,equipment |
Interventions/Control_1
After obtaining informed consent from all patients, they switched from 32G 4mm needles to 34G 4mm needles.
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
Diabetic patients who perform self-injection of insulin with pen injectors.
Key exclusion criteria
Patients who have trouble determining the pain intensity, or any other criterion associated with the questionnaire.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsunehiko Yamamoto |
Organization
Kansai Rosai Hospital
Division name
Diabetes and Endocrinology
Zip code
Address
3-1-69, Inabaso, Amagasaki city, Hyogo
TEL
06-6416-1221
tsunehiko@sannet.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Saito |
Organization
Kansai Rosai Hospital
Division name
Diabetes and Endocrinology
Zip code
Address
3-1-69, Inabaso, Amagasaki city, Hyogo
TEL
06-6416-1221
Homepage URL
dsaitou@juntendo.ac.jp
Sponsor or person
Institute
Kansai Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2016 | Year | 08 | Month | 19 | 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
| 2016 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 03 | 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
| 2016 | Year | 08 | Month | 18 | Day |
Last modified on
| 2019 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027255
