The safety and accuracy test for wearing the continuous glucose monitoring sensor "Libre Pro" on the abdomen

The safety and accuracy test for wearing the continuous glucose monitoring sensor "Libre Pro" on the abdomen - Libre Pro study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032371

Enrollment

Registered

2018-04-25

Start date

2017-04-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus

Interventions

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 (iP

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Pregnancy and the patients who are decided by their attending physician that it is inappropriate to participate in the study.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactShintaro OMORI

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

omorishintaro@marianna-u.ac.jp+81-44-722-2121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

The safety and accuracy test for wearing the continuous glucose monitoring sensor &quot;Libre Pro&quot; on the abdomen