UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012088 |
|---|---|
| Receipt number | R000012285 |
| Scientific Title | Questionnaire Survey of Patients Using Accu-chek mobile |
| Date of disclosure of the study information | 2013/10/23 |
| Last modified on | 2020/12/24 11:26:55 |
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Basic information
Public title
Questionnaire Survey of Patients Using Accu-chek mobile
Acronym
QSACM
Scientific Title
Questionnaire Survey of Patients Using Accu-chek mobile
Scientific Title:Acronym
QSACM
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the opinions of both patients and medical providers on Accu-check mobile after providing the machine to patients
Basic objectives2
Others
Basic objectives -Others
Assessment of manipulation by patients and medical providers, and effect on quality of life of patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Evaluation on manipulation of SMBG devices (needle and monitor),
2) Impact on psychological and physical stress,
comparing SMBG devices currently in use
Key secondary outcomes
1) Function of SMBG devices that would be found from the point of medical providers
2) Discrepancy of needs of patients and medical providers
3) Evaluation of Accu-chek mobile by medical providers
4) Possibility of lowering efforts by medical providers
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
SMBG machine and lancet device currently prescribed / Accu-chek mobile
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with diabetes mellitus and receiving insulin or GLP-1 receptor agonist treatment under SMBG (self-monitoring of blood glucose)
Key exclusion criteria
patients who don't agree to this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Matsuda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Depertment of Endocrinology and Diaebtes
Zip code
350-8550
Address
1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL
+81-49-228-3564
matsudam-ind@umn.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Matsuda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Depertment of Endocrinology and Diaebtes
Zip code
350-8550
Address
1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL
+81-49-228-3564
Homepage URL
matsudam-ind@umin.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Roche Diagnostics Japan
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
Saitama Medical Center, Saitama Medical University
Roche Diagnostics Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Saitama Medical Center, Saitama Medical Univ.
Address
1981, Kamoda, Kawagoe-shi, Saitama-ken, JAPAN
Tel
049-228-3902
smcrinri@saitama-med.ac.jp
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
埼玉医科大学総合医療センター
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 21 | Day |
Last modified on
| 2020 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012285
| 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 |
