Freestyle Libre Use in Real Life: Efficacy and Acceptance

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: Type 1 diabetic patients freestyle libre

• Registration Number: NCT03703999
• Lead Sponsor: University of Padova

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.

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 Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-12
• Primary Completion: 2019-04-01
• Study Completion: 2019-09-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
type 1 diabetic patients freestyle Libre	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

Primary Outcome Measures

Name	Time	Method
HbA1c	after 3 and 6 months	changes in HbA1c values

Secondary Outcome Measures

Name	Time	Method
changes in hypoglycemia fear	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)
changes in therapy satisfaction	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)
hypoglycemic episodes	after 3 and 6 months	number of hypoglycemic episodes
insulin use	after 3 and 6 months	changes in insulin dose (unit/Kg)
weight	after 3 and 6 months	changes in weight (Kg)

Trial Locations

Locations (1)

University of Padova; 🇮🇹 Padova, Italy