UMIN-CTR Clinical Trial

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

Type I and Type II diabetic patients

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

ARKRAY, Inc.

Institute

Department

Personal name

Organization

ARKRAY, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

09

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

09

Month

22

Day

Last modified on

2018

Year

06

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033407