UMIN-CTR Clinical Trial

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

diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Not applicable

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

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

Date of disclosure of the study information

2018

Year

04

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

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 related information

Registered date

2018

Year

04

Month

25

Day

Last modified on

2018

Year

04

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036787