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Recruitment status
Unique ID issued by UMIN UMIN000026761
Receipt No. R000027920
Scientific Title A filed survey on SMBG reports from individuals with diabetes
Date of disclosure of the study information 2017/03/29
Last modified on 2017/03/29

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Basic information
Public title A filed survey on SMBG reports from individuals with diabetes
Acronym positive SMBG cross-sectional study
Scientific Title A filed survey on SMBG reports from individuals with diabetes
Scientific Title:Acronym 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
1st name
Middle name
Last name Yutaka Seino
Organization Kansai Electric Power Medical Research Institute
Division name Director General
Zip code
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
1st name
Middle name
Last name Nagaaki Tanaka
Organization Kansai Electric Power Medical Research Institute
Division name Division of Diabetes and Endocrinology Yutaka Seino Distinguished Center for Diabetes Research
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
Date of protocol fixation
2016 Year 09 Month 07 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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