UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter Survey of subcutaneous induration and effect on glycemic control by the guidance of site rotation in the elderly insulin-injecting patients with diabetes
Title of the study (Brief title)	Multicenter Survey of subcutaneous induration and effect on glycemic control by the guidance of site rotation in the elderly insulin-injecting patients with diabetes
Region	Japan

Condition
Condition	type 1 diabetes type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aims of study were to calculate subcutaneous induration and effect on glycemic control by the guidance of site rotation in the elderly insulin-injecting patients with diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Toal insulin dose HbA1c(%)
Key secondary outcomes	Frequency of subcutaneous induration Risk factors of subcutaneous induration Frequency of hypoglycemia

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	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	The guidance of site rotation is performed once
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	65 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1,Patient who aged 65 years and over 2,Patient who treated insulin over a year
Key exclusion criteria	1,Patient who the attending physician judged impossible to participate 2,Unreceived informed consent
Target sample size	100

Research contact person
Name of lead principal investigator	Shunji horikawa
Organization	JA Onomichi general Hospital
Division name	Department of pharmacy
Address	Hirahara 1-10-23 Onomichi,Hiroshima,Japan
TEL	0848228111
Email	shi.horikawa@hirokouren.or.jp

Public contact
Name of contact person	Shunji horikawa
Organization	JA Onomichi general Hospital
Division name	Department of pharmacy
Address	Hirahara 1-10-23 Onomichi,Hiroshima,Japan
TEL	0848228111
Homepage URL
Email	shi.horikawa@hirokouren.or.jp

Sponsor
Institute	JA Onomichi general Hospital Department of pharmacy
Institute
Department

Funding Source
Organization	JA Onomichi general Hospital Hirahara 1-10-23 Onomichi,Hiroshima,Japan
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Ja Yoshida Hospital Mihara Medical Association Hospital Sera Central Hospital Shobara Redcross Hospital Miyoshi central Hospital Kita Hiroshima Hospital
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 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 05 Day
Anticipated trial start date	2017 Year 10 Month 05 Day
Last follow-up date	2018 Year 08 Month 06 Day
Date of closure to data entry	2018 Year 08 Month 06 Day
Date trial data considered complete	2018 Year 08 Month 31 Day
Date analysis concluded	2019 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 28 Day
Last modified on	2018 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033528