UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008965
Receipt number R000010514
Scientific Title The efficacy of structured self-monitoring of blood glucose (SMBG)on glycemic control in non-insulin treated type 2 diabetes
Date of disclosure of the study information 2012/11/01
Last modified on 2017/06/01 19:40:02

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Basic information

Public title

The efficacy of structured self-monitoring of blood glucose (SMBG)on glycemic control in non-insulin treated type 2 diabetes

Acronym

Structured SMBG Study

Scientific Title

The efficacy of structured self-monitoring of blood glucose (SMBG)on glycemic control in non-insulin treated type 2 diabetes

Scientific Title:Acronym

Structured SMBG Study

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of structured SMBG on glycemic control in non-insulin treated type 2 diabetes

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in HbA1c in 6 months

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

structured SMBG

Interventions/Control_2

Routine SMBG

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. diet, exercise, and/or OHA-treated type 2 diabetes
2. Age >= 20
3. male and female
4. diabetes duration >= 6 months
5. 6.5% <= HbA1c < 8.5%
6. No improvement of HbA1c > 0.5% in 2 months
7. No SMBG performance in 3 months
8. Informed consent

Key exclusion criteria

1. insulin or GLP-1 receptor agonists-treated patients
2. pregnancy
3. alcoholism, depression, mental diseases
4. Abnormal Hemoglobin
5. Severe complications and comorbidities
6. Malignancy
7. Treatment changes in 2 months

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuya Inagaki

Organization

Kyoto University

Division name

Department of Diabetes and Clinical Nutrition

Zip code


Address

54 Syogoin Kawaramachi Sakyo-ku Kyoto

TEL

075-751-3560

Email

harasima@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Harashima

Organization

Kyoto University

Division name

Department of Diabetes and Clinical Nutrition

Zip code


Address

54 Syogoin Kawaramachi Sakyo-ku Kyoto

TEL

075-751-3560

Homepage URL


Email

harasima@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Kyoto University

Organization

Division

Category of Funding Organization

Other

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

2012 Year 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2012 Year 09 Month 23 Day

Date of IRB


Anticipated trial start date

2012 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

2012 Year 09 Month 23 Day

Last modified on

2017 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010514


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name