University of Padova
Padova, Italy
NCT Number: NCT03703999
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.
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Notify Me18 year and older
All sexes
Observational
Padova, Italy
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients selected to use freestyle libre
Time frame: after 3 and 6 months
changes in HbA1c values
Time frame: after 3 and 6 months
Evaluation of hypoglycemia fear through a validated questionnaires, Hypoglycemic Fear Survey (HFS-II). The questionnaires is composed by 33 questions with a Linkert Scale (0-4)
Time frame: after 3 and 6 months
Evaluation of changes in therapy satisfaction through a validated questionnaires, Diabetes Treatment Satisfaction Questionnaire (DTSQ). The questionnaires is composed by 8 questions with a Linkert Scale (0-6)
Time frame: after 3 and 6 months
number of hypoglycemic episodes
Time frame: after 3 and 6 months
changes in weight (Kg)
Time frame: after 3 and 6 months
changes in insulin dose (unit/Kg)
University of Padova
Other
Efficacy and Acceptance of Freestyle Libre Abbott Use in Real Life in Type 1 Diabetic Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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