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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032371
Receipt No. R000036787
Scientific Title The safety and accuracy test for wearing the continuous glucose monitoring sensor "Libre Pro" on the abdomen
Date of disclosure of the study information 2018/04/25
Last modified on 2018/04/25

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Basic information
Public title The safety and accuracy test for wearing the continuous glucose monitoring sensor "Libre Pro" on the abdomen
Acronym Libre Pro study
Scientific Title The safety and accuracy test for wearing the continuous glucose monitoring sensor "Libre Pro" on the abdomen
Scientific Title:Acronym 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
1st name
Middle name
Last name Akio OTA
Organization St. Marianna University School of Medicine Toyoko Hospital
Division name Lifestyle-related Disease Center
Zip code
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
1st name
Middle name
Last name Shintaro OMORI
Organization St. Marianna University School of Medicine Toyoko Hospital
Division name Lifestyle-related Disease Center
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 04 Month 26 Day
Date of IRB
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

Other
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

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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