UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017236
Receipt number R000017870
Scientific Title Evaluation of the efficacy of self monitoring blood glucose for gestational diabetes mellitus with onediagnostic reference point abnormality in new
Date of disclosure of the study information 2015/04/22
Last modified on 2015/06/02 15:15:58

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Basic information

Public title

Evaluation of the efficacy of self monitoring blood glucose for gestational diabetes mellitus with onediagnostic reference point abnormality in new

Acronym

Evaluation of the efficacy of self monitoring blood glucose for gestational diabetes mellitus with one point abnormality

Scientific Title

Evaluation of the efficacy of self monitoring blood glucose for gestational diabetes mellitus with onediagnostic reference point abnormality in new

Scientific Title:Acronym

Evaluation of the efficacy of self monitoring blood glucose for gestational diabetes mellitus with one point abnormality

Region

Japan


Condition

Condition

gestational diabetes mellitus

Classification by specialty

Endocrinology and Metabolism Obstetrics and Gynecology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We quantify the efficacy of self monitoring blood blucose for gestational diabetes mellitus with one point abnomality.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

body weight
HbA1c
glycoalbumin plasma glucose
Insrinogenic index
Continuous glucose monitoring
neonatal complications
pregnancy complications


Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Continuous glucose monitoring

Interventions/Control_2

Continuous glucose monitoring
Self monitoring blood glucose

Interventions/Control_3

Continuous glucose monitoring

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

45 years-old >=

Gender

Female

Key inclusion criteria

1)pregnant women with nomal glucose tolerance

2)gestational diabetes mellitus with one point abnomality on 75gOGTT in second pregnancy trimeter

3)gestational diabetes mellitus with two or three point abnomality in second pregnancy trimeter

Key exclusion criteria

multiple pregnancy
requiring treatment with medication
infected patients of the human immunodeficiency virus/ HBV/HCV.
Overt diabetes

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiaki Hanafusa

Organization

Osaka Medical College

Division name

Department of Internal Medicine (I)

Zip code


Address

2-7 Daigaku-machi, Takatsuki City, Osaka

TEL

072-683-1221

Email

hanafusa@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Miwa Kuzutani

Organization

Osaka Medical College

Division name

Department of Internal Medicine (I)

Zip code


Address

2-7 Daigaku-machi, Takatsuki City, Osaka

TEL

072-683-1221

Homepage URL


Email

in-1357@poh.osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical College

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

osaka medical center and reserch institute for maternal and child health

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

大阪医科大学附属病院(大阪府)
大阪府立母子保健総合医療センター(大阪府)


Other administrative information

Date of disclosure of the study information

2015 Year 04 Month 22 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

2015 Year 01 Month 05 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 05 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

2015 Year 04 Month 22 Day

Last modified on

2015 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017870


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name