UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of Penneedleplus for the patients using insulin
Title of the study (Brief title)	Penneedleplus study
Region	Japan

Condition
Condition	patients with diabetes, using insulin
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the efficacy of Penneedleplus for the patients with diabetes, using insulin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The level of pain by VAS, after using each needle for 3 days
Key secondary outcomes	The important points for the patients using insulin needle

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
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 patients using nanopass are randomized to perform crossover study. They use penneedleplus for the first 3 days and penneedle for the second 3 days.
Interventions/Control_2	The patients using nanopass are randomized to perform crossover study. They use penneedle for the first 3 days and penneedleplus for the second 3 days.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1.Patients with diabetes using insulin. 2.Agreemnt with paper.
Key exclusion criteria	Inappropriate for the research
Target sample size	30

Research contact person
Name of lead principal investigator	Junko Sato
Organization	Juntendo University Shizuoka Hospital
Division name	Department of Diabetes, Endocrinology and Metabolism
Address	1129 Nagaoka, Izunokunishi, Shizuoka, Japan
TEL	055-948-3111
Email	jsato@juntendo.ac.jp

Public contact
Name of contact person	Junko Sato
Organization	Juntendo University Shizuoka Hospital
Division name	Department of Diabetes, Endocrinology and Metabolism
Address	1129 Nagaoka, Izunokunishi, Shizuoka, Japan
TEL	055-948-3111
Homepage URL
Email	jsato@juntendo.ac.jp

Sponsor
Institute	Juntendo University Shizuoka Hospital
Institute
Department

Funding Source
Organization	Juntendo University Shizuoka Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2017 Year 10 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 10 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 22 Day
Last modified on	2018 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033886