UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056627 |
|---|---|
| Receipt number | R000064720 |
| Scientific Title | Glucose Insight in Pregnancy Study |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2026/01/05 22:37:12 |
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Basic information
Public title
Glucose Insight in Pregnancy Study
Acronym
GIP study
Scientific Title
Glucose Insight in Pregnancy Study
Scientific Title:Acronym
GIP study
Region
| Japan |
Condition
Condition
pregnant women
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology | Pediatrics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evidence building for constructing blood glucose management goals for pregnancy and labor in pregnancies complicated by abnormal glucose metabolism
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigation of blood glucose variability during the entire gestational and parturient period in pregnant women with normal glucose tolerance and those with abnormal glucose metabolism
Key secondary outcomes
1) To examine the association between glycemic variables during the entire gestational and parturient periods and perinatal complications in pregnant women with abnormal glucose metabolism
2) Obtain the latest and best evidence on the association between blood glucose changes during the entire pregnancy and delivery period, abnormal glucose metabolism, and perinatal complications in all pregnant women through a systematic review
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Normal glucose tolerance pregnant women (NGT) and pregnant women with diabetes in pregnancy (DIP)
Key exclusion criteria
1) Those with other comorbidities (cardiac disease, collagen disease, blood disease, psychiatric disease, etc.)
2) Those who have had severe symptoms such as contact dermatitis caused by adhesive plasters or medical tapes in the past
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Marie |
| Middle name | |
| Last name | FURUTA |
Organization
Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name
perinatal epidemiology
Zip code
606-8507
Address
53 Kawahara-cho Shogo-in, Sakyo-ku, Kyoto
TEL
075-751-3972
harashima.shinichi.38m@st.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | HARASHIMA |
Organization
Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name
perinatal epidemiology
Zip code
606-8507
Address
53 Kawahara-cho Shogo-in, Sakyo-ku, Kyoto
TEL
075-751-3972
Homepage URL
harashima.shinichi.38m@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
| 2025 | Year | 01 | Month | 06 | 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
450
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
| 2019 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to build credible evidence regarding Diabetes in Pregnancy (DIP) gestational and peripartum glycemic control goals to be used in the development of practice guidelines. To this end, we aim to achieve each of the following objectives, with the ultimate goal of.
(1) To evaluate glycemic variability during all gestational and parturient periods in Normal Glucose Tolerance (NGT) as well as DIP pregnant women using continous glucose monitoring (CGM).
(2) To examine the association between perinatal complications and blood glucose variability during the entire gestational and parturitional phases in DIP pregnant women.
(3) Obtain the latest and best evidence on the association between glycemic variability, abnormal glucose metabolism, and perinatal complications during all gestational and parturient periods in all pregnant women through a systematic review.
Management information
Registered date
| 2025 | Year | 01 | Month | 04 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064720
