NCT02776007

Patients Perceptions of Using the "Libre" System Compared With Conventional SMBG in Adolescents With Type 1 Diabetes The Libre Sat Trial

Patients Perceptions of Using the Libre System Compared With Conventional SMBG in Adolescents With Type 1 Diabetes The Libre Sat Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The Libre- flash glucose monitoring system is an episodic real-time data on demand device. This means that patients can measure their glucose level when they choose by scanning the device, while at the same time a sensor automatically measures and continuously stores glucose readings day and night. Every scan shows the current glucose reading and the last 8 hours of glucose. There are no alarms and the system does not require calibration. In the present study we aim to evaluate treatment satisfaction and comfort using the Libre flash glucose monitoring system compared to conventional Self Measurement of Blood Glucose (SMBG) in adolescents with type 1 diabetes that discontinued using continuous glucose monitoring. The second aim of the study is to evaluate the rate of use and the impact of Libre use compared to Self-Measurement of Blood Glucose among adolescents who are sub-optimally controlled and stopped using Continuous Glucose Monitoring. The study is an investigator initiated study, single-center, randomized, parallel study of 12 weeks with an optional cross-over 12 weeks extension period .

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Libre Flash CGMS
DEVICE	Self-Measurement Blood Glucose	Patients will use their personal glucose meter to perform Self-Measurement Blood Glucose

Timeline

• Start date: 2016-07-01
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2016-05-18
• Last updated: 2022-08-09

Locations

1 site across 1 country: Israel