UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008280 |
|---|---|
| Receipt number | R000009759 |
| Scientific Title | The effect of continuous glucose monitoring system useing at the diabetes mellitus outpatient clinic |
| Date of disclosure of the study information | 2012/06/28 |
| Last modified on | 2012/09/25 18:02:48 |
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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
Cross-over
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
With the data of SMBG,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
30
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
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
jsato@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine, Department of Metabolism and Endocrinology
Institute
Department
Personal name
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
Secondary IDs
Secondary IDs
YES
Study ID_1
24-129
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 | 06 | Month | 28 | 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 | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | 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 | 06 | Month | 27 | Day |
Last modified on
| 2012 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009759
