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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021738
Receipt No. R000025071
Scientific Title Study of blood glucose kinetics and glycemic control methods with the Real-Time Continuous Glucose Monitoring During labor of gestational diabetes and normal pregnant women.
Date of disclosure of the study information 2016/05/01
Last modified on 2017/04/02

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Basic information
Public title Study of blood glucose kinetics and glycemic control methods with the Real-Time Continuous Glucose Monitoring During labor of gestational diabetes and normal pregnant women.
Acronym Study of blood glucose kinetics and glycemic control methods with the Real-Time Continuous Glucose Monitoring During labor of gestational diabetes and normal pregnant women.
Scientific Title Study of blood glucose kinetics and glycemic control methods with the Real-Time Continuous Glucose Monitoring During labor of gestational diabetes and normal pregnant women.
Scientific Title:Acronym Study of blood glucose kinetics and glycemic control methods with the Real-Time Continuous Glucose Monitoring During labor of gestational diabetes and normal pregnant women.
Region
Japan

Condition
Condition gestational diabetes mellitus
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is possible to obtain a real-time detailed data. This is the analysis in related to blood glucose kinetics after labor onset come to a detailed clarification about diabetes merger, gestational diabetes, and normal pregnant women , which has not been made up to now.With this result, it is possible to obtain a new knowledge of the blood glucose fluctuations in the delivery time of after labor onset come.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes plasma glucose level from labor onset to 48hours after delivery.
Real-Time Continuous Glucose Monitoring
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Medtronic MiniMed 600 series (CGM transmitter, CGM en light sensor, care link professional) real-time personal CGM using: puncture of tiny needle by (Continuous Glucose Monitoring sustained glucose measurement).
Up to six days puncture duration (two days after delivery from after labor onset come)
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 50 patients
Specific disease in a patient of interest: abnormal glucose metabolism
( GDM, diabetes merger pregnancy)
1( GDM, diabetes merger pregnancy) pregnancy 25 people.
2 normal pregnant women 25 people of our hospital delivery schedule.
Key exclusion criteria 1, If there is a withdrawal of consent from research subjects
2,If complications requiring treatment by the enforcement of SAP system appears
3,If the entire present study has been discontinued
4,For other reasons, if the principal investigator has determined that the appropriate discontinuation of study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Masuyama
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Obstetrics & Gynecology
Zip code
Address Shikata kita-ku Okayama Okayama
TEL 086-235-7320
Email jotajjjo@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Jota Maki
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Obstetrics & Gynecology
Zip code
Address Shikata kita-ku Okayama Okayama
TEL 086-235-7320
Homepage URL
Email jotajjjo@yahoo.co.jp

Sponsor
Institute Department of Obstetrics & Gynecology Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Department of Obstetrics & Gynecology Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization Other
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
2016 Year 05 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 Enrolling by invitation
Date of protocol fixation
2016 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 05 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
2016 Year 04 Month 01 Day
Last modified on
2017 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025071

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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