Freestyle Libre Use in Real Life: Efficacy and Acceptance
Freestyle Libre Use in Real Life: Efficacy and Acceptance
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.
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
Inclusion Criteria:

 -  Male and female participants of at least 18 years of age

 -  Diagnosis of type 1 diabetes mellitus (diagnosed according to World Health
 Organization criteria) for at least 1 year

 -  Availability to wear Freestyle Libre sensor

 -  Signature of informed consent

 Exclusion Criteria:

 -  Pregnancy, breastfeeding, intention to undergo pregnancy

 -  Known allergies to skin patches or disinfectants used during the study.

 -  Skin lesions, irritation, redness, edema in sites where sensors can be applied, as
 this might interfere with sensor's placement

 -  Use of drugs that may interfere with glucose metabolism (such as steroids) unless they
 are chronic therapies whose dosage has remained stable over the past 3 months and is
 expected to remain stable during the study period.

 -  Severe medical or psychological conditions, which, in the opinion of the medical team,
 may compromise patients' safety while using freestyle LIbre sensor

 -  Patients enrolled in other clinical trials.

 -  patients that usually wear other continuous glucose monitoring system