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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034547
Receipt No. R000039084
Scientific Title Glucose tolerance evaluation by continuous glucose monitoring (CGM) after gestational diabetes
Date of disclosure of the study information 2018/10/31
Last modified on 2018/10/24

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Basic information
Public title Glucose tolerance evaluation by continuous glucose monitoring (CGM) after gestational diabetes
Acronym Glucose tolerance evaluation by CGM after GDM
Scientific Title Glucose tolerance evaluation by continuous glucose monitoring (CGM) after gestational diabetes
Scientific Title:Acronym Glucose tolerance evaluation by CGM after GDM
Region
Japan

Condition
Condition Gestational Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate glucose tolerance by continuous blood glucose monitoring after birth of a gestational diabetic patient and compare it with the data of postpartum women who did not develop gestational diabetes. And to investigate the possibility of predicting onset of impaired glucose tolerance before obvious and residual of impaired glucose tolerance.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Differences in blood glucose fluctuation between 7 and 14 days in GDM group and non-GDM group.
Key secondary outcomes Evaluate the difference such as HbA1c, glycoalbumin and Continuous overlapping net Glycemic Action (CONGA), SD, Mean, Max, Min and J-index in CGM data, between GDM group and non-GDM group.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Postpartum patients of Gestational diabetes attach CGM between 7 to 14 days.The patient takes a test meal one day during wearing.
Interventions/Control_2 Healthy postpartum women are control group and attach CGM between 7 to 14 days.They takes a test meal one day during wearing.
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
49 years-old >=
Gender Female
Key inclusion criteria GDM group:Women who gave birth at University Hospital Kyoto Prefectural University of Medicine or Adachi Hospital.And those who have been diagnosed with gestational diabetes during pregnancy and are over 6 months and within 3 years after birth and after resuming menstruation,who are not pregnant or lactating.
Patients who gave birth at Adachi Hospital are introducted to University Hospital Kyoto Prefectural University of Medicine when after birth examination.

non-GDM group:Women who did not diagnosed gestational diabetes during pregnancy and are over 6 months and within 3 years after birth and after resuming menstruation, who are not pregnant or lactating. We do not limit hospitals they gave birth.
Key exclusion criteria We exclude patients who have been diagnosed as borderline type diabetes or diabetes type after childbirth and obvious diabetes mellitus during pregnancy and pregnancy with diabetes mellitus.
Patients who the doctor judged inappropriate for participation in the trial, patients who declared non-acceptance of participation are excluded.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Fukui
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan
Division name Department of Endocrinology and Metabolism
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL 075-252-5505
Email michiaki@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aya Kitae
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan
Division name Department of Endocrinology and Metabolism
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan.
TEL 075-252-5506
Homepage URL
Email kitaeaya@koto.kpu-m.ac.jp

Sponsor
Institute Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan
Institute
Department

Funding Source
Organization Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan
Organization
Division
Category of Funding Organization Self funding
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 京都府立医科大学付属病院

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 31 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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 11 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
2018 Year 10 Month 17 Day
Last modified on
2018 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039084

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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