Freestyle Libre Use in Real Life: Efficacy and Acceptance
Efficacy and Acceptance of Freestyle Libre Abbott Use in Real Life in Type 1 Diabetic Patients
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 20, 2018
CompletedFirst Posted
Study publicly available on registry
October 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMarch 27, 2020
March 1, 2020
10 months
September 20, 2018
March 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c
changes in HbA1c values
after 3 and 6 months
Secondary Outcomes (5)
changes in hypoglycemia fear
after 3 and 6 months
changes in therapy satisfaction
after 3 and 6 months
hypoglycemic episodes
after 3 and 6 months
weight
after 3 and 6 months
insulin use
after 3 and 6 months
Study Arms (1)
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
Interventions
patients selected to use freestyle libre
Eligibility Criteria
type 1 diabetic patients selected by clinicians to start Freestyle Libre use
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Padova
Padua, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
September 20, 2018
First Posted
October 12, 2018
Study Start
June 1, 2018
Primary Completion
April 1, 2019
Study Completion
September 1, 2019
Last Updated
March 27, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share