UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety and accuracy test for wearing the continuous glucose monitoring sensor "Libre Pro" on the abdomen
Title of the study (Brief title)	Libre Pro study
Region	Japan

Condition
Condition	diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluating the safety and glucose measurement accuracy of Flash glucose-monitoring sensor "Libre Pro" attached to the abdomen on the diabetic patients attending the St. Marianna university school of medicine Lifestyle-related disease center.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety assessment of Libre Pro sensor attached to the abdomen for 2 weeks by the following questions Q1. Whether there is a pain generated by skin puncture when the sensor is attached to the body Q2. Whether there is a bleeding or infection at the insertion site Q3. Whether there is a dermatitis on the site where the sensor attached Q4. Whether there is an uncomfortable wearing and its stress Q5. Whether there is difficulty in daily life due to wearing the sensor
Key secondary outcomes	Assessment of the glucose measurement accuracy regarding Libre Pro sensor attached to the abdomen for 2 weeks by the following test 1. Correspondence of SG values between "Libre Pro" sensors at the arm and abdomen over a 2 week-period and Accuracy of these sensors against the calibrated conventional CGM sensor "iPro2" as reference 2. Ability of each CGM device and the glucose test strips to detect rapid fluctuation of venous plasma glucose (VPG) during an oral glucose tolerance test

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Correspondence of SG values between two Libra Pro (LP) sensors at different body sites was investigated and the accuracy of these sensors was also compared with calibrated conventional CGM sensors (iPro2) wearable on the arm or abdomen for reference over a 2-week period. In addition, the ability of each device to detect rapid fluctuation of venous plasma glucose (VPG) during an oral glucose tolerance test was evaluated by the periodic blood samplings performed 5 times every 30-min.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients attended the Lifestyle-related Diseases Center of St. Marianna University Toyoko Hospital (Kawasaki, Japan). Their medications included oral hypoglycemic agents, insulin, and injectable glucagon-like peptide-1 receptor agonists. Written informed consent was obtained from all participants
Key exclusion criteria	Pregnancy and the patients who are decided by their attending physician that it is inappropriate to participate in the study.
Target sample size	20

Research contact person
Name of lead principal investigator	Akio OTA
Organization	St. Marianna University School of Medicine Toyoko Hospital
Division name	Lifestyle-related Disease Center
Address	3-435, Kosugi-machi, Nakahara-ku, Kawasaki, Kanagawa 211-0063, Japan
TEL	+81-44-722-2121
Email	a2oota@marianna-u.ac.jp

Public contact
Name of contact person	Shintaro OMORI
Organization	St. Marianna University School of Medicine Toyoko Hospital
Division name	Lifestyle-related Disease Center
Address	3-435, Kosugi-machi, Nakahara-ku, Kawasaki, Kanagawa 211-0063, Japan
TEL	+81-44-722-2121
Homepage URL
Email	omorishintaro@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine Toyoko Hospital, Lifestyle-related Disease Center
Institute
Department

Funding Source
Organization	Not applicable
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	#3532
Org. issuing International ID_1	The Ethics Committee of St. Marianna University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	聖マリアンナ医科大学東横病院（神奈川県）/ St. Marianna University School of Medicine Toyoko Hospital

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 26 Day
Anticipated trial start date	2017 Year 04 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 25 Day
Last modified on	2018 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036787