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Freestyle Libre Use in Real Life: Efficacy and Acceptance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03703999
Recruitment Status : Completed
First Posted : October 12, 2018
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Daniela Bruttomesso, University of Padova

Study Description
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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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 Device: Type 1 diabetic patients freestyle libre

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

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Efficacy and Acceptance of Freestyle Libre Abbott Use in Real Life in Type 1 Diabetic Patients
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Device: Type 1 diabetic patients freestyle libre
patients selected to use freestyle libre


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 3 and 6 months ]
    changes in HbA1c values


Secondary Outcome Measures :
  1. changes in hypoglycemia fear [ 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)

  2. changes in therapy satisfaction [ 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)

  3. hypoglycemic episodes [ Time Frame: after 3 and 6 months ]
    number of hypoglycemic episodes

  4. weight [ Time Frame: after 3 and 6 months ]
    changes in weight (Kg)

  5. insulin use [ Time Frame: after 3 and 6 months ]
    changes in insulin dose (unit/Kg)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
type 1 diabetic patients selected by clinicians to start Freestyle Libre use
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703999


Locations
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Italy
University of Padova
Padova, Italy
Sponsors and Collaborators
University of Padova
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Daniela Bruttomesso, MD, PhD, University of Padova
ClinicalTrials.gov Identifier: NCT03703999    
Other Study ID Numbers: 4465/AO/18
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Daniela Bruttomesso, University of Padova:
flash glucose monitoring
HbA1c
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases