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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008978
Receipt No. R000010531
Scientific Title The effect of continuous glucose monitoring system useing at the diabetes mellitus outpatient clinic
Date of disclosure of the study information 2012/09/25
Last modified on 2013/10/23

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Basic information
Public title The effect of continuous glucose monitoring system useing at the diabetes mellitus outpatient clinic
Acronym The effect of CGM at the diabetes mellitus outpatient clinic
Scientific Title The effect of continuous glucose monitoring system useing at the diabetes mellitus outpatient clinic
Scientific Title:Acronym The effect of CGM at the diabetes mellitus outpatient clinic
Region
Japan

Condition
Condition Diabetes Mellitus
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of useing CGM(iPro2)at
the diabetes mellitus outpatient clinic
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of HbA1c
Improvement of glucose movement
Decrease of hypoglycemia
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment Behavior,custom
Interventions/Control_1 With the data of CGM, more suitable medication and life habit are suggested to the patient for better treatment.
Interventions/Control_2 Without the data of CGM, more suitable medication and life habit are suggested to the patient for better treatment.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patient whose HbA1c is 6.9-9.4% for three months.
2.Patients doing nutrition and exercise therapy.
3.Patients doing insulin therapy excluding BOT.
Key exclusion criteria 1.Patients with serious liver,renal,heart,pancreatic insufficiency.
2.Patients with cancer
3.Patients with anemia or plastocytopenia
4.Patients with serious diabetic complications
5.Patients with serious infection
6.Patients before and after the operation
7.Patients of heavy alcoholic drinker
8.Pregnant women
9.Patients with hepatic viruses
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikeda, Fuki
Organization Juntendo University Graduate School of Medicine
Division name Department of Metabolism and Endocrinology
Zip code
Address 2-1-1Hongo,Bunkyoku,Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sato, Junko
Organization Juntendo University Graduate School of Medicine
Division name Department of Metabolism and Endocrinology
Zip code
Address
TEL
Homepage URL
Email jsato@juntendo.ac.jp

Sponsor
Institute Juntendo University Graduate School of Medicine, Department of Metabolism and Endocrinology
Institute
Department

Funding Source
Organization Juntendo University Graduate School of Medicine, Department of Metabolism and Endocrinology
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 YES
Study ID_1 12-86
Org. issuing International ID_1 Juntendo University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 25 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 Terminated
Date of protocol fixation
2012 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 10 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
2012 Year 09 Month 25 Day
Last modified on
2013 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010531

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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