UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief 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.
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	Hisashi Masuyama
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Obstetrics & Gynecology
Address	Shikata kita-ku Okayama Okayama
TEL	086-235-7320
Email	jotajjjo@gmail.com

Public contact
Name of contact person	Jota Maki
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Obstetrics & Gynecology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 03 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000025071