UMIN-CTR Clinical Trial

Basic information
Public title	Data acquisition and accuracy confirmation test for device measurements, fingertip blood glucose levels, and venous blood glucose levels
Acronym	Data acquisition and accuracy confirmation test for device measurements, fingertip blood glucose levels, and venous blood glucose levels
Scientific Title	Data acquisition and accuracy confirmation test for device measurements, fingertip blood glucose levels, and venous blood glucose levels
Scientific Title:Acronym	Data acquisition and accuracy confirmation test for device measurements, fingertip blood glucose levels, and venous blood glucose levels
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective is to acquire device measurements and blood glucose levels and to confirm the accuracy.
Basic objectives2	Others
Basic objectives -Others	Accuracy of device measurements compared to reference blood glucose values
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accuracy of device measurements compared to reference blood glucose values
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy male and female whose ages are 20 to <65 years old. (2) Subjects whose serum glucose level are < 126 mg/dL. (3) Subjects whose BMI are 18.5 to <30 kg/m2. (4) Subjects who agree with the given description and express informed consent via telecommunication and written documents.
Key exclusion criteria	(1) Systolic pressure <90 mmHg (2) Subjects who are pregnant or lactating. (3) Subjects who donated over 200ml blood components or whole blood within the past 4 weeks prior to the current study. (4) Male Subjects who donated over 400ml whole blood within the past 12 weeks prior to the current study. (5) Female who donated over 400ml whole blood within the past 16 weeks prior to the current study. (6) Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added. (7) Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added. (8) Subjects who are participating in other clinical studies, or who finished clinical study within the last 4 weeks. (9) a) Subjects with disease on heart, liver, kidney or other organs complications. b) Subjects with a previous history of disease on circulatory organs. c) Subjects who are contracting diabetes. (10) Subjects with gastrointestinal diseases and/or a history of surgery affecting digestion and absorption (11) Subjects with alcohol sensitivity (12) Subjects with a previous history of feeling sick after blood sampling. (13) Subjects with metal and/or latex allergic contact dermatitis (14) Subjects with allergies to glucose tolerance. (15) Subjects who have had an abnormal ECG (arrhythmia) indicated in the past. (16) Subjects who wear false nails, and those whose white part of the tip of the nail is extended by 3 mm or more. (17) Subjects who are constantly taking certain drug medicine, (18) Subjects who drink alcohol a lot (19) Subjects who work irregular shifts or at midnight. (20) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size	112

Research contact person
Name of lead principal investigator	1st name Mitsuhiro Middle name Last name Zeida
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Zip code	6190284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	080-2546-4385
Email	Mitsuhiro_Zeida@suntory.co.jp

Public contact
Name of contact person	1st name Tomoki Middle name Last name Uchida
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Zip code	6190284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0381
Homepage URL
Email	Tomoki_Uchida@suntory.co.jp

Sponsor
Institute	Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization	Suntory Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Macromill, Inc. Healthcare Systems Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee of Healthcare Systems Co., Ltd.
Address	1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel	052-734-8885
Email	soumu@hc-sys.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

Other administrative information
Date of disclosure of the study information	2022 Year 10 Month 07 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	Preinitiation
Date of protocol fixation	2022 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date	2022 Year 10 Month 08 Day
Last follow-up date	2022 Year 11 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational, single-center, open-label study

Management information
Registered date	2022 Year 10 Month 04 Day
Last modified on	2022 Year 10 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055945