MedTrace Logo

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

NCT02776007 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-09

No results posted yet for this study

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

Interventions

DEVICE

Libre Flash CGMS

DEVICE

Self-Measurement Blood Glucose

Patients will use their personal glucose meter to perform Self-Measurement Blood Glucose

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Rabin Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02776007 on ClinicalTrials.gov