UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017236 |
|---|---|
| Receipt number | R000017870 |
| Scientific Title | Evaluation of the efficacy of self monitoring blood glucose for gestational diabetes mellitus with onediagnostic reference point abnormality in new |
| Date of disclosure of the study information | 2015/04/22 |
| Last modified on | 2015/06/02 15:15:58 |
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Basic information
Public title
Evaluation of the efficacy of self monitoring blood glucose for gestational diabetes mellitus with onediagnostic reference point abnormality in new
Acronym
Evaluation of the efficacy of self monitoring blood glucose for gestational diabetes mellitus with one point abnormality
Scientific Title
Evaluation of the efficacy of self monitoring blood glucose for gestational diabetes mellitus with onediagnostic reference point abnormality in new
Scientific Title:Acronym
Evaluation of the efficacy of self monitoring blood glucose for gestational diabetes mellitus with one point abnormality
Region
| Japan |
Condition
Condition
gestational diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We quantify the efficacy of self monitoring blood blucose for gestational diabetes mellitus with one point abnomality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body weight
HbA1c
glycoalbumin plasma glucose
Insrinogenic index
Continuous glucose monitoring
neonatal complications
pregnancy complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Continuous glucose monitoring
Interventions/Control_2
Continuous glucose monitoring
Self monitoring blood glucose
Interventions/Control_3
Continuous glucose monitoring
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1)pregnant women with nomal glucose tolerance
2)gestational diabetes mellitus with one point abnomality on 75gOGTT in second pregnancy trimeter
3)gestational diabetes mellitus with two or three point abnomality in second pregnancy trimeter
Key exclusion criteria
multiple pregnancy
requiring treatment with medication
infected patients of the human immunodeficiency virus/ HBV/HCV.
Overt diabetes
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Hanafusa |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (I)
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka
TEL
072-683-1221
hanafusa@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miwa Kuzutani |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (I)
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka
TEL
072-683-1221
Homepage URL
in-1357@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
osaka medical center and reserch institute for maternal and child health
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
大阪医科大学附属病院（大阪府）
大阪府立母子保健総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 22 | 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
| 2015 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | 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
| 2015 | Year | 04 | Month | 22 | Day |
Last modified on
| 2015 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017870
