UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A filed survey on SMBG reports from individuals with diabetes
Title of the study (Brief title)	positive SMBG cross-sectional study
Region	Japan

Condition
Condition	diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To improve quality of life(QOL) and healthy life expectancy of patients with diabetes, we aim to establish a diabetes education and care model with active use of self-monitoring of blood glucose(SMBG).
Basic objectives2	Others
Basic objectives -Others	We explore the relationship between psychological status and QOL in patients with diabetes and establishment of doctor-patient communication with use of SMBG.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Correlation between DTR-QOL score and POMS2 score and self-reported patients' attitude toward SMBG. Evaluation of self-reported doctors' attitude toward SMBG.
Key secondary outcomes	Relationship between DTR-QOL score and POMS2 score and SMBG frequency, duration, insulin injection frequency, age, sex, type of diabetes and HbA1c.

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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1)patients with type 1 or type 2 diabetes mellitus using SMBG for moer than 3 months. 2)patients whose doctors confirm eligible for answering questionnaires of the study. 3)patients who aged 20-90 years.
Key exclusion criteria	1)patients who are suspected to have dementia and/or psychiatry disorders. 2)patients whose doctors confirm ineligible for answering questionnaires of the study.
Target sample size	2000

Research contact person
Name of lead principal investigator	Yutaka Seino
Organization	Kansai Electric Power Medical Research Institute
Division name	Director General
Address	2-1-7, Fukushima, Fukushima-ku, Osaka, Japan
TEL	06-6458-5821
Email	seino.yutaka@e2.kepco.co.jp

Public contact
Name of contact person	Nagaaki Tanaka
Organization	Kansai Electric Power Medical Research Institute
Division name	Division of Diabetes and Endocrinology Yutaka Seino Distinguished Center for Diabetes Research
Address	2-1-7, Fukushima, Fukushima-ku, Osaka, Japan
TEL	06-6458-5821
Homepage URL
Email	nagaakitanaka@nifty.com

Sponsor
Institute	Kansai Electric Power Medical Research Institute Division of Diabetes and Endocrinology Yutaka Seino Distinguished Center for Diabetes Research
Institute
Department

Funding Source
Organization	Terumo Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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 03 Month 29 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 09 Month 07 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry	2017 Year 01 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The aim of the study is to investigate the correlations of doctor-patient relationship through SMBG and mental states and QOL of patinets with diabetes mellitus using SMBG.

Management information
Registered date	2017 Year 03 Month 29 Day
Last modified on	2017 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027920