Freestyle Libre Use in Real Life: Efficacy and Acceptance

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703999
• Other study ID #: 4465/AO/18
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: March 2020
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• Type 1 diabetic patients freestyle libre
patients selected to use freestyle libre

Locations

Country	Name	City	State
Italy	University of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	changes in HbA1c values	after 3 and 6 months
Secondary	changes in hypoglycemia fear	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)	after 3 and 6 months
Secondary	changes in therapy satisfaction	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)	after 3 and 6 months
Secondary	hypoglycemic episodes	number of hypoglycemic episodes	after 3 and 6 months
Secondary	weight	changes in weight (Kg)	after 3 and 6 months
Secondary	insulin use	changes in insulin dose (unit/Kg)	after 3 and 6 months