Freestyle Libre Use in Real Life: Efficacy and Acceptance

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Type 1 diabetic patients freestyle libre


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 1 diabetic patients freestyle Libre<br>group of type 1 diabetic patients that will be selected to use Freestyle libre on the basis of clinicians decisions and reimbursement criteria | Device: Type 1 diabetic patients freestyle libre<br>* patients selected to use freestyle libre<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | changes in HbA1c values | after 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in hypoglycemia fear | 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) | after 3 and 6 months | 
| changes in therapy satisfaction | 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) | after 3 and 6 months | 
| hypoglycemic episodes | number of hypoglycemic episodes | after 3 and 6 months | 
| weight | changes in weight (Kg) | after 3 and 6 months | 
| insulin use | changes in insulin dose (unit/Kg) | after 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flash glucose monitoring, HbA1c