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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002986
Receipt No. R000003622
Scientific Title Effect of continuous glucose monitering on glycemic control in diabetes mellitus
Date of disclosure of the study information 2010/03/01
Last modified on 2010/01/06

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Basic information
Public title Effect of continuous glucose monitering on glycemic control in diabetes mellitus
Acronym Effect of CGM on glycemic control
Scientific Title Effect of continuous glucose monitering on glycemic control in diabetes mellitus
Scientific Title:Acronym Effect of CGM on glycemic control
Region
Japan

Condition
Condition Diabetes mellitaus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify the effect of CGM on glycemic control in patients with diabetes mellitus
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1)the average of blood glucose
2)variability of blood glucose
Key secondary outcomes the change of blood glucose, comliance, others

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Measurement of24h blood glucose by using CGMS Gold and adjust doses of OHA or insulin. Then, HbA1c and blood glucose are checked at 0, 1, 3, and 6 months.
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

Not applicable
Gender Male and Female
Key inclusion criteria Men and women over 20 years old who fulfill the following criteria:1)disease of any type of Diabetes mellitus,
2) The level of HbA1c is more than 6.5%.
Key exclusion criteria 1)Risk of bleeding
2) An idividual who is judged as inappropriate for this study by a medical doctor
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name tadashi yamakawa
Organization Yokohama City University Medical Center
Division name Department of Diabetes
Zip code
Address 4-57 Urafune-cho,minami-ku,yokohama,232-0024,Japan
TEL 045-261-5656
Email

Public contact
Name of contact person
1st name
Middle name
Last name tadashi yamakawa
Organization Yokohama City University Medical Center
Division name Department of Diabetes
Zip code
Address 4-57 Urafune-cho,minami-ku,yokohama,232-0024,Japan
TEL 045-261-5656
Homepage URL
Email

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization Yokohama City University Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 横浜市立大学医学部附属市民総合医療センター

Other administrative information
Date of disclosure of the study information
2010 Year 03 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 Preinitiation
Date of protocol fixation
2010 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2013 Year 07 Month 01 Day
Date of closure to data entry
2014 Year 01 Month 01 Day
Date trial data considered complete
2014 Year 06 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 06 Day
Last modified on
2010 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003622

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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