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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029241
Receipt No. R000033407
Scientific Title Study of the performance and safety of a new glucose measurement system for diabetic patients
Date of disclosure of the study information 2017/09/25
Last modified on 2018/06/07

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Basic information
Public title Study of the performance and safety of a new glucose measurement system for diabetic patients
Acronym Study of the performance and safety of a new glucose measurement system for diabetic patients
Scientific Title Study of the performance and safety of a new glucose measurement system for diabetic patients
Scientific Title:Acronym Study of the performance and safety of a new glucose measurement system for diabetic patients
Region
Japan

Condition
Condition Type I and Type II diabetic patients
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the performance and safety of the new glucose measurement system in diabetic patients compared with existing system as the control.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Correlation between the values measured by the test system (test group) and the values measured by existing system
2. Difference depending on test system application site
Key secondary outcomes Secondary outcomes
1. Condition around measurement site
2. Stability of the test system
3. Questionnaire survey (sense of use, pain, points of improvement etc.)

Safety evaluation outcomes
1. Presence or absence of study equipment (test system and control system) defects and their frequency
2. Adverse events and side effects, and their frequency

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Blood sugar measurement (New glucose measurement system)
Blood sugar measurement (Existing glucose measurement system)
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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients aged 20 years or over and under 70 years (at the time of consent)
2. Patients with HbA1c of 6% or higher (patients with higher levels are preferred)
3. Male or female (regardless of sex)
4. Patients who have sufficient understanding and can provide voluntary written consent for participation in the study after sufficient explanation
Key exclusion criteria 1. Patients with diabetes related complications (if not attending hospital due to complications and living a normal lifestyle, the patient can be registered; however, if diabetic neuropathy is detected during the study, the patient will be discontinued from the study)
2. Patients with skin disease at the evaluation site
3. Patients currently undergoing the xylose absorption test
4. Patients currently taking pralidoxime methiodide
5. Patients currently participating in another clinical trial
6. Patients who are otherwise judged to be unsuitable for this clinical trial by the investigators
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Tsutsui
Organization ARKRAY, Inc.
Division name Product Development Division
Zip code
Address Yousuien-nai, 59 Gansuin-cho, Kamigyo-ku, Kyoto, JAPAN
TEL 050-5830-1004
Email tsutsuik@arkray.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Arai
Organization Mebix, Inc.
Division name Research Promotion Division
Zip code
Address Toranomon 15 Mori Building, 2-8-10, Toranomon, Minato-ku, Tokyo
TEL 03-4362-4504
Homepage URL
Email ark-sensor@mebix.co.jp

Sponsor
Institute ARKRAY, Inc.
Institute
Department

Funding Source
Organization ARKRAY, Inc.
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 09 Month 25 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 05 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 28 Day
Last follow-up date
2018 Year 01 Month 20 Day
Date of closure to data entry
2018 Year 01 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 22 Day
Last modified on
2018 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033407

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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