Freestyle Libre Use in Real Life: Efficacy and Acceptance | NCT03703999

Studies
Freestyle Libre Use in Real Life: Efficacy and Acceptance

NCT03703999

Sponsor

University of Padova

Status

Completed

Last Update Posted

Mar 27, 2020Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Diabetes Mellitus, Type 1

Interventions

Type 1 diabetic patients freestyle libre

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Apr 1, 2019Actual

Completion Date

Sep 1, 2019Actual

First Submitted Date

Sep 20, 2018

First Submission Date that Met QC Criteria

Oct 10, 2018

First Posted Date

Oct 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2020

Last Update Posted Date

Mar 27, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Type 1 diabetic patients freestyle libre	Device	patients selected to use freestyle libre	type 1 diabetic patients freestyle Libre

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c	changes in HbA1c values	after 3 and 6 months

Secondary Outcomes

Measure	Description	Time Frame
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
changes in therapy satisfaction

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

type 1 diabetic patients selected by clinicians to start Freestyle Libre use

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

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