UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028883
Receipt number R000033056
Scientific Title The Effect of Continuous Glucose Monitoring On Glycemic Control In Gestational Diabetes Mellitus
Date of disclosure of the study information 2017/09/01
Last modified on 2020/03/05 12:09:38

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Basic information

Public title

The Effect of Continuous Glucose Monitoring On Glycemic Control In Gestational Diabetes Mellitus

Acronym

The Effect of Continuous Glucose Monitoring In Gestational Diabetes Mellitus

Scientific Title

The Effect of Continuous Glucose Monitoring On Glycemic Control In Gestational Diabetes Mellitus

Scientific Title:Acronym

The Effect of Continuous Glucose Monitoring In Gestational Diabetes Mellitus

Region

Japan


Condition

Condition

Gestational Diabetes Mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine if there is correlation 75gOGTT and CGM.
To determine CGM improves glycemic control in GDM.
To determine CGM improves pregnancy outcomes in GDM.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Glycemic control(Blood glucose, HbA1c) in perinatal period.

Key secondary outcomes

75gOGTT, data of CGM, data of SMBG, pregnancy outcomes.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Behavior,custom

Interventions/Control_1

CGM will be performed for 14days on the day of first examination and in one month.

Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

patients with gestational diabetes mellitus diagnosed by Japanise criteria of GDM in Bokutoh Hospital.

Key exclusion criteria

Concomitant disease or condition that may compromise patient

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Aya
Middle name
Last name Yoshihara

Organization

Tokyo Metropolitan Bokutoh Hospital

Division name

Internal Medicine

Zip code

130-8575

Address

4-23-15, Koutoh-bashi, Sumida-ku, Tokyo

TEL

03-3633-6151

Email

aya.yoshihara@med.toho-u.ac.jp


Public contact

Name of contact person

1st name Aya
Middle name
Last name Yoshihara

Organization

Tokyo Metropolitan Bokutoh Hospital

Division name

Internal Medicine

Zip code

130-8575

Address

4-23-15, Koutoh-bashi, Sumida-ku, Tokyo

TEL

03-3633-6151

Homepage URL


Email

aya.yoshihara@med.toho-u.ac.jp


Sponsor or person

Institute

Tokyo Metropolitan Bokutoh Hospital, Department of Internal Medicine

Institute

Department

Personal name



Funding Source

Organization

Tokyo Metropolitan Hospital

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Metropolitan Hospital

Address

4-23-15, Koutoh-bashi, Sumida-ku, Tokyo

Tel

03-3633-6151

Email

bo_rinsyo_kenkyu@tmhp.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



Other administrative information

Date of disclosure of the study information

2017 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

Completed

Date of protocol fixation

2017 Year 03 Month 24 Day

Date of IRB

2017 Year 04 Month 17 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2018 Year 07 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

2017 Year 08 Month 29 Day

Last modified on

2020 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033056


Research Plan
Registered date File name
2020/03/05 研究計画書(期間変更) Yoshihara20170801.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name