UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035349
Receipt No. R000040277
Scientific Title An intervention study for evaluation of SMBG use and educational support of doctors in patients with type 2 diabetes
Date of disclosure of the study information 2019/01/01
Last modified on 2018/12/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Objectives
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

Assessment
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.

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yutaka Seino
Organization Kansai Electric Power Medical Institute
Division name Yutaka Seino Distinguished Center for Diabetes Research
Zip code
Address 2-1-7, Fukushima, Fukushima-ku, Osaka, Japan
TEL +81-6-6458-5821
Email seino.yutaka@e2.kepco.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Nagaaki Tanaka
Organization Kansai Electric Power Medical Institute
Division name Yutaka Seino Distinguished Center for Diabetes Research
Zip code
Address 2-1-7, Fukushima, Fukushima-ku, Osaka, Japan
TEL +81-6-6458-5821
Homepage URL
Email nagaakitanaka@nifty.com

Sponsor
Institute Center for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital
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
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
2019 Year 01 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 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
Other related information

Management information
Registered date
2018 Year 12 Month 23 Day
Last modified on
2018 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040277

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.