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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028883
Receipt No. 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 2019/02/28

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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
Middle name
Last name Aya Yoshihara
Organization Tokyo Metropolitan Bokutoh Hospital
Division name Internal Medicine
Zip code
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
Middle name
Last name Aya Yoshihara
Organization Tokyo Metropolitan Bokutoh Hospital
Division name Internal Medicine
Zip code
Address 4-23-15, Koutoh-bashi, Sumida-ku, Tokyo
TEL 03-3633-6151
Homepage URL
Email aya.yoshihara@med.toho-u.ac.jp

Sponsor
Institute Tokyo Metropolitan Bokutoh Hospital, Department of Internal Medicine
Institute
Department

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
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
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 No longer recruiting
Date of protocol fixation
2017 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 09 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
2017 Year 08 Month 29 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033056

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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