UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To investigate whether one-minute status examination for category fluency is useful to evaluate the ability of mastering insulin self-injection technique within 1 week
Title of the study (Brief title)	To investigate whether one-minute status examination for category fluency is useful to evaluate the ability of mastering insulin self-injection technique within 1 week
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the score of cognitive tests between inpatients with type2 diabetes who can master insulin self-injection technique within 1 week and those who can not, when they learn how to inject insulin for the first time
Basic objectives2	Others
Basic objectives -Others	To investigate the cognitive tests which is useful to evaluate the ability of mastering insulin self-injection technique within 1 week
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare the score of verbal fluency tests`the names of animals` between inpatients with type2 diabetes who can master insulin self-injection technique within 1 week and those who can not, when they learn how to inject insulin for the first time
Key secondary outcomes	To compare the total number of verbal fluency tests:the common nouns which begine with `a`,`ka`and`si` between inpatients with type2 diabetes who can master insulin self-injection technique within 1 week and those who can not, when they learn how to inject insulin for the first time To compare the score of MMSE(Minimental state examination) between the 2 groups

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subject:inpatients with type 2 diabetes who can not master insulin self-injection technique within 1 week Contorol: inpatients with type 2 diabetes who can master insulin self-injection technique within 1 week
Key exclusion criteria	1.The patients with history of stroke 2.The patients with psychiatry diseases which may represent cognitive dysfunctions such as depression 3.Diabetic ketoacidosis 4.Thyroid hormone disorders 5.Vitamin deficiency disorders 6.Patients with infectious diseases within 3 months 7.The individuals who stop to generate "the town they have visited" on vebal fluency tests within 1 minute 8.The individuals the attending doctor or the researcher judge inappropriate to be in this study
Target sample size	100

Research contact person
Name of lead principal investigator	Masayo Yamada
Organization	Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
Division name	Department of Endocrinology & Metabolism
Address	Katsura-chou 132, Sakae-ku, Yokohama, Kanagawa, Japan
TEL	045-891-2171
Email	masayo-y@cameo.plala.or.jp

Public contact
Name of contact person	Minami Taichi
Organization	Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
Division name	Department of Endocrinology & Metabolism
Address	Katsura-chou 132, Sakae-ku, Yokohama, Kanagawa, Japan
TEL	045-891-2171
Homepage URL
Email	ksqdd034@yahoo.co.jp

Sponsor
Institute	Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
Institute
Department

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)

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 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 01 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	cross-sectional study The inpatients with type 2 diabetes who start insulin therapy for the first time will be divided into 2 groups. The subjects are inpatients who can not master insulin self-injection technique within 1 week. The controls are inpatients who can master insulin self-injection technique within 1 week.

Management information
Registered date	2016 Year 01 Month 26 Day
Last modified on	2017 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023929