Freestyle Libre Use in Real Life: Efficacy and Acceptance

University of Padova

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Type 1 diabetic patients freestyle libre

Study type: Observational

Funder types: Other

Identifiers

NCT03703999

4465/AO/18

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

type 1 diabetic patients freestyle Libre

Description:

group of type 1 diabetic patients that will be selected to use Freestyle libre on the basis of clinicians decisions and reimbursement criteria

Treatment:

Device: Type 1 diabetic patients freestyle libre