UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016074 |
|---|---|
| Receipt number | R000018676 |
| Scientific Title | Pharmacy diabetes care program of self-monitoring of blood glucose: Cross-over trial |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2014/12/27 19:38:16 |
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Basic information
Public title
Pharmacy diabetes care program of self-monitoring of blood glucose: Cross-over trial
Acronym
COMPASS-SEP
Scientific Title
Pharmacy diabetes care program of self-monitoring of blood glucose: Cross-over trial
Scientific Title:Acronym
COMPASS-SEP
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of a diabetes educational program using self-monitoring blood glucose in pharmacy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
Adherence, Changes in daily eating and exercise habits
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Self-monitoring blood glucose: 7 times a day
Interventions/Control_2
Self-monitoring blood glucose: 2 times a day
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
Patients with Type 2 diabetes
higher than HbA1c 7% over 3 months
Key exclusion criteria
patients with insulin/GLP-1 therapy
kidny disease, dialyzed patient
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi OKADA |
Organization
National Hospital Organization Kyoto Medical center
Division name
Department of Preventive Medicine Clinical Research Institute for Endocrine and Metabolic disease
Zip code
Address
1-1Mukaihata Fukakusa Fushimi Kyoto
TEL
075-641-9161
bufobufo.ok@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi OKADA |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Preventive Medicine Clinical Research Institute for Endocrine and Metabolic disease
Zip code
Address
1-1Mukaihata Fukakusa Fushimi Kyoto
TEL
075-641-9161
Homepage URL
bufobufo.ok@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
OMRON Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
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
| 2015 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | 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
| 2014 | Year | 12 | Month | 27 | Day |
Last modified on
| 2014 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018676
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
