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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028482
Receipt No. R000032604
Scientific Title Evaluation of usefulness of voice guidance for self monitoring blood glucose.
Date of disclosure of the study information 2017/08/01
Last modified on 2019/01/08

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Basic information
Public title Evaluation of usefulness of voice guidance for self monitoring blood glucose.
Acronym Evaluation of usefulness of voice guidance for self monitoring blood glucose.
Scientific Title Evaluation of usefulness of voice guidance for self monitoring blood glucose.
Scientific Title:Acronym Evaluation of usefulness of voice guidance for self monitoring blood glucose.
Region
Japan

Condition
Condition Patients on Insulin therapy/ GLP-1 therapy
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to consider whether the voice guidance function of the blood glucose meter is useful for acquiring measurement process. Medical staff evaluate whether SMBG introduction to patients was able to proceed smoothly.The voice guidance function is whether it helped to understand how to cope with acquisition of patient's own measurement process, understanding of measurement value, error indication etc. after returning home. Usefulness verification including psychological aspects by voice guidance is carried out.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of the questionnaire result for patient.
-Usability,Fisical evaluation,Intension use
Key secondary outcomes The questionnaire result for Medical staff. (When the study start.)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 TERUMO Blood Glucose Monitoring System/MEDISAFE Fit Smile with voice guidance
Interventions/Control_2 TERUMO Blood Glucose Monitoring System/MEDISAFE Fit Smile
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ・Diabetes patient who newly conducts self-monitoring of blood glucose with evaluation object device. (The patient administered with insulin or GLP-1 receptor agonist of type 2 DM.)
Key exclusion criteria ・The patient who has difficulty in understanding of the blood glucose meter by cognitive ability or eyesight drop.
・In addition, the patient whom it was judged an evaluation PI or sub-PI to be unsuitable for evaluation participation.
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masaharu Morohoshi
Organization Clinic for Lifestyle-related disease, Sanraku Hospital
Division name Diabetes
Zip code
Address 2-5,Kanda-Surugadai,Chiyoda-ku,Tokyo Japan
TEL 03-3292-3981
Email yuki_sonoda@terumo.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yuki Sonoda
Organization TERUMO CORPORATION
Division name Hospital Products Company
Zip code
Address Tokyo Opera City Tower 49F,3-20-2,Nishi-Shinjuku,Shinjuku-ku,Tokyo Japan
TEL 03-6742-8202
Homepage URL
Email yuki_sonoda@terumo.co.jp

Sponsor
Institute Clinic for Lifestyle-related disease, Sanraku Hospital
Institute
Department

Funding Source
Organization TERUMO 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
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

Other administrative information
Date of disclosure of the study information
2017 Year 08 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 Completed
Date of protocol fixation
2017 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 01 Day
Last modified on
2019 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032604

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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