UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033676
Receipt number 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 10:17:52

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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 or person

Institute

Kansai Electric Power Medical Research Institute

Institute

Department

Personal name



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

Value
https://center6.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