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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012088
Receipt No. R000012285
Scientific Title Questionnaire Survey of Patients Using Accu-chek mobile
Date of disclosure of the study information 2013/10/23
Last modified on 2016/04/21

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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&#39;t agree to this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Matsuda
Organization Saitama Medical Center, Saitama Medical University
Division name Depertment of Endocrinology and Diaebtes
Zip code
Address 1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL +81-49-228-3564
Email matsudam-ind@umn.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Matsuda
Organization Saitama Medical Center, Saitama Medical University
Division name Depertment of Endocrinology and Diaebtes
Zip code
Address 1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL +81-49-228-3564
Homepage URL
Email matsudam-ind@umin.ac.jp

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Roche Diagnostics Japan
Institute
Department

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
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 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 No longer recruiting
Date of protocol fixation
2013 Year 05 Month 01 Day
Date of IRB
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
2016 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012285

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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