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Completed

NCT Number: NCT03703999

Freestyle Libre Use in Real Life: Efficacy and Acceptance

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Padova

Padova, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Type 1 diabetic patients freestyle libre

Device

patients selected to use freestyle libre

Primary outcomes

  1. HbA1c

    Time frame: after 3 and 6 months

    changes in HbA1c values

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 12, 2018
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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