UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021738 |
|---|---|
| Receipt number | 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 10:39:15 |
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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
| Obstetrics 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
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
jotajjjo@yahoo.co.jp
Sponsor or person
Institute
Department of Obstetrics & Gynecology Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025071
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
