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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033676
Receipt No. R000038395
Scientific Title An intervention study for evaluation of SMBG use and educational support of doctors in patients with type 2 diabetes: multicenter alternative study
Date of disclosure of the study information 2018/09/01
Last modified on 2019/08/16

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Basic information
Public title An intervention study for evaluation of SMBG use and educational support of doctors in patients with type 2 diabetes:
multicenter alternative study
Acronym Positive2SMBG multicenter study
Scientific Title An intervention study for evaluation of SMBG use and educational support of doctors in patients with type 2 diabetes:
multicenter alternative study
Scientific Title:Acronym Positive2SMBG multicenter study
Region
Japan

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

Objectives
Narrative objectives1 To evaluate whether doctors' intervention with self-monitoring of blood glucose device ameliorates glycemic control and QOL in their patients with type 2 diabetes.
Basic objectives2 Others
Basic objectives -Others To establish the diabetes care model with utilising SMBG to support patients with diabetes for their health promotion and QOL improvement.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes Intrergroup difference in DTR-QOL score through the study period(2-3 months)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 treatment with doctors' self-care support using SMBG data-management system
Interventions/Control_2 conventional treatment
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. patients with type 2 diabetes using insulin injection for more than 3 months2. patients who are capable of answering questionnaires.
3. patients whose HbA1care 7.0% or higher, lower than 11.0%
Key exclusion criteria 1. patients who are susceptible of dementia or menta disorders
2. patients who are regarded as inappropriate to attend the study by research administrator or attending researcher
3. patients with severe liver or kidney disorders
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name Seino
Organization Kansai Electric Power Medical Research Institute
Division name Division of Diabetes and Endocrinology Yutaka Seino Distinguished Center for Diabetes Research
Zip code 553-0003
Address 2-1-7, Fukushima, Fukushima-ku, Osaka, Japan
TEL 06-6458-5821
Email yutaka.seino.hp@gmail.com

Public contact
Name of contact person
1st name Nagaaki
Middle name
Last name Tanaka
Organization Kansai Electric Power Medical Research Institute
Division name Division of Diabetes and Endocrinology Yutaka Seino Distinguished Center for Diabetes Research
Zip code 553-0003
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
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japan Association of Diabetes Education and Care
Address 2-2-4, Central Blg. 8F, Koujimachi, Chiyoda-ku, Tokyo, Japan
Tel 03-3514-1721
Email office@nittokyo.or.jp

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 自由が丘横山内科クリニック(北海道)
かなもり内科(神奈川県)
向ヶ丘久保田内科(神奈川県)
近藤医院(東京都)
高橋ファミリークリニック(愛知県)
福田内科医院(大分県)
かぎもとクリニック(京都府)
かわもと医院(大阪府)
かしいクリニック(大阪府)
よこがわ内科クリニック(福岡県)
二田哲博クリニック(福岡県)
嶋田病院(福岡県)
医療法人初生会 福井中央クリニック(福井県)
岩本内科医院(香川県)
小内医院(山形県)
那珂記念クリニック(茨城県)
南昌江内科クリニック(福岡県)
松山市民病院(愛媛県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 29 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 08 Day
Last modified on
2019 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038395

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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