UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028883 |
|---|---|
| Receipt number | R000033056 |
| Scientific Title | The Effect of Continuous Glucose Monitoring On Glycemic Control In Gestational Diabetes Mellitus |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2020/03/05 12:09:38 |
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Basic information
Public title
The Effect of Continuous Glucose Monitoring On Glycemic Control In Gestational Diabetes Mellitus
Acronym
The Effect of Continuous Glucose Monitoring In Gestational Diabetes Mellitus
Scientific Title
The Effect of Continuous Glucose Monitoring On Glycemic Control In Gestational Diabetes Mellitus
Scientific Title:Acronym
The Effect of Continuous Glucose Monitoring In Gestational Diabetes Mellitus
Region
| Japan |
Condition
Condition
Gestational Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine if there is correlation 75gOGTT and CGM.
To determine CGM improves glycemic control in GDM.
To determine CGM improves pregnancy outcomes in GDM.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic control(Blood glucose, HbA1c) in perinatal period.
Key secondary outcomes
75gOGTT, data of CGM, data of SMBG, pregnancy outcomes.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
CGM will be performed for 14days on the day of first examination and in one month.
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
patients with gestational diabetes mellitus diagnosed by Japanise criteria of GDM in Bokutoh Hospital.
Key exclusion criteria
Concomitant disease or condition that may compromise patient
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Yoshihara |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Internal Medicine
Zip code
130-8575
Address
4-23-15, Koutoh-bashi, Sumida-ku, Tokyo
TEL
03-3633-6151
aya.yoshihara@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Yoshihara |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Internal Medicine
Zip code
130-8575
Address
4-23-15, Koutoh-bashi, Sumida-ku, Tokyo
TEL
03-3633-6151
Homepage URL
aya.yoshihara@med.toho-u.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Bokutoh Hospital, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Hospital
Address
4-23-15, Koutoh-bashi, Sumida-ku, Tokyo
Tel
03-3633-6151
bo_rinsyo_kenkyu@tmhp.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
| 2017 | Year | 09 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 29 | Day |
Last modified on
| 2020 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033056
