UMIN-CTR Clinical Trial

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 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
Email	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
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	IRB, Saitama Medical Center, Saitama Medical Univ.
Address	1981, Kamoda, Kawagoe-shi, Saitama-ken, JAPAN
Tel	049-228-3902
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012285