UMIN-CTR Clinical Trial

Public title

An intervention study for evaluation of SMBG use and educational support of doctors in patients with type 2 diabetes

Acronym

Positive2SMBG Study

Scientific Title

An intervention study for evaluation of SMBG use and educational support of doctors in patients with type 2 diabetes

Scientific Title:Acronym

Positive2SMBG Study

Region

Japan

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To elucidate whether doctors' involvement in evaluating of SMBG readings and establishing treatment plan provide benefit on glycemic control or QOL in type 2 diabetes patients.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Primary end points of this study were change in HbA1c levels from baseline to 6-month and change in DTR-QOL score from baseline to 6-month.

Key secondary outcomes

Secondary outcomes were included as follows: change in body weight; SMBG frequency; change in insulin doses; changes in scores of the original SMBG questionnaire.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

Patients in intervention group were able to have doctors' instruction with SMBG data-management system (HR Joint Simle Data Vision), a SMBG readings analyzer using a software that provides comprehensive summary statistics, listings and graphical spots of blood glucose profiles. These data were downloaded from a computer through Near Field Communication reader. For further education, doctors were allowed to use comprehensive educational brochures provided by Diabetes Education Card System (Japan Association of Diabetes Education and Care, Tokyo, Japan). IE patients and doctors reviewed profiles of blood glucose, discussed the target level of fasting and post-prandial glucose level and life-style modification which patients were in consent to engage.

Interventions/Control_2

Conventional treatment patients were instructed to continue ordinary SMBG testings without using the data-management system.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

Eligible patients included 1) those with T2D aged 20 years or older and younger than 75 years, 2) those using SMBG for more than 3 months; 3) those with HbA1c 7.0 % or higher and lower than 11.0 %; 4) those capable of answering the questionnaires used in the present study; and 5) those receiving insulin and/or GLP-1 receptor agonist (GLP-1RA) as SMBG is allowed for those using injectables under the Japanese national health insurance coverage.

Key exclusion criteria

Patients were excluded if they were 1) susceptible to dementia and/or psychological and/or psychiatric disorders; 2) receiving only GLP-1RA as an injection therapy; or 3) considered to be ineligible for this study by physicians-in-charge.

Target sample size

200

Name of lead principal investigator

1st name	Yutaka
Middle name
Last name	Seino

Organization

Kansai Electric Power Medical Institute

Division name

Yutaka Seino Distinguished Center for Diabetes Research

Zip code

553-0003

Address

2-1-7, Fukushima, Fukushima-ku, Osaka, Japan

TEL

+81-6-6458-5821

Email

seino.yutaka@e2.kepco.co.jp

Name of contact person

1st name	Nagaaki
Middle name
Last name	Tanaka

Organization

Kansai Electric Power Medical Institute

Division name

Yutaka Seino Distinguished Center for Diabetes Research

Zip code

553-0003

Address

2-1-7, Fukushima, Fukushima-ku, Osaka, Japan

TEL

+81-6-6458-5821

Homepage URL

Email

nagaakitanaka@nifty.com

Institute

Center for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital

Institute

Department

Personal name

Organization

Terumo Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kansai Electric Power Hospital

Address

2-1-7, Fukushima, Fukushima-ku, Osaka, Japan

Tel

06-6458-5821

Email

koga.kazuhiro@c3.kepco.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2017

Year

10

Month

27

Day

Date of IRB

Anticipated trial start date

2017

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

12

Month

23

Day

Last modified on

2019

Year

12

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040277