UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026761
Receipt number 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 17:10:39

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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