NCT03703999

Freestyle Libre Use in Real Life: Efficacy and Acceptance

Efficacy and Acceptance of Freestyle Libre Abbott Use in Real Life in Type 1 Diabetic Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim of the study is to evaluate efficacy of freestyle Libre system (flash glucose monitoring) in real life in term of Glycated Haemoglobin reduction and acceptance of the system evaluated through validated questionnaires after 3 and 6 months of device's use.

Detailed description

Freestyle Libre is a new technology developed to monitor glycemic values in diabetic patients. The system is available in Italy from 2014 but in Veneto region reimbursement for insulin treated diabetic patients is available from august 2017. International trial (for example Impact trial) demonstrated efficacy of the system (reduction of the time spent in hypoglycemia). Aim of this study is to evaluate efficacy in real life in term of glycated haemoglobin (HbA1c) reduction. The investigators will enrollee in this trial all type 1 diabetic patients that will start to use the system, on the basis of clinicians decisions and reimbursement criteria. Investigators will evaluate changes in HbA1c and changes in hypoglycameia fear and therapy acceptance through validated questionnaires after 3 and 6 months of system use

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Type 1 diabetic patients freestyle libre	patients selected to use freestyle libre

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-04-01
• Completion: 2019-09-01
• First posted: 2018-10-12
• Last updated: 2020-03-27

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study