Clinical trial NCT03703999: Freestyle Libre Use in Real Life: Efficacy and Acceptance
Official title: Efficacy and Acceptance of Freestyle Libre Abbott Use in Real Life in Type 1 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: flash glucose monitoring
HbA1c
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: type 1 diabetic patients selected by clinicians to start Freestyle Libre use

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: after 3 and 6 months
Secondary outcomes:
measure: changes in hypoglycemia fear
timeFrame: after 3 and 6 months
measure: changes in therapy satisfaction
timeFrame: after 3 and 6 months
measure: hypoglycemic episodes
timeFrame: after 3 and 6 months
measure: weight
timeFrame: after 3 and 6 months
measure: insulin use
timeFrame: after 3 and 6 months
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University of Padova
Study officials:
References: