Freestyle Libre Use in Real Life: Efficacy and Acceptance
NCT ID: NCT03703999
Last Updated: 2020-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2018-06-01
2019-09-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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type 1 diabetic patients freestyle Libre
group of type 1 diabetic patients that will be selected to use Freestyle libre on the basis of clinicians decisions and reimbursement criteria
Type 1 diabetic patients freestyle libre
patients selected to use freestyle libre
Interventions
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Type 1 diabetic patients freestyle libre
patients selected to use freestyle libre
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Padova
OTHER
Responsible Party
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Daniela Bruttomesso
MD, PhD
Locations
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University of Padova
Padua, , Italy
Countries
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Other Identifiers
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4465/AO/18
Identifier Type: -
Identifier Source: org_study_id
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