Back to results

Accuracy of Freestyle Libre

Primary Purpose

Diabetes Type 1

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

flash glucose monitoring

About this trial

This is an interventional supportive care trial for Diabetes Type 1 focused on measuring diabetes type 1, flash glucose monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 18 years
Diagnosis of diabetes mellitus type 1 ( diagnosed according to World Health Organization criteria ) for at least one year
Body Mass Index ( BMI ) < 35 kg / m²
Willingness to wear the device and to comply with the study protocol during the entire duration of the same
No restrictions linked to glycated hemoglobin ( HbA1c )
Signature of informed consent before any study-related procedure

Exclusion Criteria:

Pregnancy, breast-feeding, planning pregnancy, or refuse to use contraception during the study period (for female subjects).
Known allergies to patches or skin disinfectants used during the study.
skin lesions, irritation, redness, edema, in the possible application of the sensor sites that may interfere with the placement of the device or the detection accuracy of test results.
blood donations in the 3 months preceding the study.
Use of drugs that can interfere with glucose metabolism (such as steroids) unless it is chronic therapies whose dosage has remained stable over the last 3 months and is expected to remain stable during the study period.
serious medical or psychological conditions that in the opinion of the medical team could compromise patient safety during study participation.
Patients enrolled in other clinical trials.
known disorders of the adrenal glands, pancreatic tumors, or insulinomas
Inability of the patient to comply with the study procedures

Sites / Locations

University of PadovaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

flash glucose monitoring

Arm Description

Patients will use a device: Freestyle Libre for 14 days

Outcomes

Primary Outcome Measures

accuracy of freestyle Libre flash monitoring

accuracy of freestyle Libre flash monitoring measured as MARD respect to blood glucose (YSI) during CRC visit and respect to glucometer during home setting

Secondary Outcome Measures

Evaluate the accuracy of the Free Style Libre for each day of use and during normoglycaemia ( between 70 and 180 mg / dl )

accuracy of freestyle Libre flash monitoring during normoglycaemia (between 70 and 180 mg / dl) measured as MARD respect to blood glucose (YSI) during CRC visit and respect to glocometer during home setting, accuracy for each day of use measured as MARD respect to glucometer

Evaluate the accuracy of the Free Style Libre for each day of use and during hypoglicaemia ( < 70 mg / dl )

accuracy of freestyle Libre flash monitoring during hypogliacemia (< 70 mg / dl) measured as MARD respect to blood glucose (YSI) during CRC visit and respect to glucometer during home setting,

Evaluate the accuracy of the Free Style Libre for each day of use and during hyperglicemia ( >180 mg / dl )

accuracy of freestyle Libre flash monitoring measured as MARD respect to blood glucose (YSI) during CRC visit and respect to glucometer during home setting,

Full Information

NCT ID

NCT02734745

First Posted

April 6, 2016

Last Updated

October 3, 2017

Sponsor

University of Padova

1. Study Identification

Unique Protocol Identification Number

NCT02734745

Brief Title

Accuracy of Freestyle Libre

Official Title

Accuracy of Flash Glucose Monitoring Freestyle Libre (Abbott) in Home Setting and In-patient Setting During Hypo - Hyperglycemia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2016 (Actual)

Primary Completion Date

December 1, 2017 (Anticipated)

Study Completion Date

December 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Padova

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is an open-label, mono-centre, interventional study.The aim of this trial is to assess accuracy and reliability of a flash glucose monitoring system, the freestyle Libre (Abbott, CA, USA), in patients with type 1 diabetes.

Detailed Description

Objective: To assess accuracy and reliability of a new-to-market flash glucose monitoring system, the freestyle Libre (Abbott, CA, USA), in patients with type 1 diabetes. Study design: open-label, mono-centre interventional study. Patients will wear freestyle Libre for 14 days in the home setting. There will be no limitations in food intake or in physical activity, but patients will have at least 7 finger-stick/days. Patients will have 2 visits in our clinical center and in these visits we'll compare freestyle Libre values with blood sampling to determine glucose values with YSI, during euglycemia and during glucose excursion and induced hypo-hyperglycemia. Study population: 48 patients will be included in this trial. Every patient will wear device for 14 days at home and during 2 visits at CRC Study endpoints: main endpoint will be the evaluation of freestyle Libre accuracy during real life compared to glucometer values and to YSI glucose values (during 2 visits). A separate analysis will be performed on the accuracy of the freestyle Libre in the hypoglycaemic (defined as a blood glucose value ≤3.9 mmol/L) and hyperglycaemic area (defined as a blood glucose value ≥10.0 mmol/L). Additionally, a separate analysis will be performed to assess device performance and accuracy per day of device life. If patients enrolled in the study use Dexcom G4 or G5 (CGM) and wanted to continue to use it, he/she can do so. In this case we can compare the accuracy of Libre even towards Dexcom G4/G5 device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Type 1

Keywords

diabetes type 1, flash glucose monitoring

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

flash glucose monitoring

Arm Type

Experimental

Arm Description

Patients will use a device: Freestyle Libre for 14 days

Intervention Type

Device

Intervention Name(s)

flash glucose monitoring

Intervention Description

Patients will use Freestyle Libre for 14 days at home, during this period they will have to perform at least 7 measurements of capillary blood glucose per day . Patients also will go to our clinical center on two separate occasions , to run a test breakfast. In one of the two occasions it will be specifically induced a moderate initial hyperglycemia and subsequent hypoglycemia . During the test meal and in the subsequent hours for a total of 6 hours , will be carried out frequent blood sampling for measurement of blood glucose using the Yellow Springs glucose analyzer ( YSI system ) , simultaneous measurements with Freestyle Libre and with glucometer.

Primary Outcome Measure Information:

Title

accuracy of freestyle Libre flash monitoring

Description

accuracy of freestyle Libre flash monitoring measured as MARD respect to blood glucose (YSI) during CRC visit and respect to glucometer during home setting

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Evaluate the accuracy of the Free Style Libre for each day of use and during normoglycaemia ( between 70 and 180 mg / dl )

Description

Time Frame

14 days

Title

Evaluate the accuracy of the Free Style Libre for each day of use and during hypoglicaemia ( < 70 mg / dl )

Description

accuracy of freestyle Libre flash monitoring during hypogliacemia (< 70 mg / dl) measured as MARD respect to blood glucose (YSI) during CRC visit and respect to glucometer during home setting,

Time Frame

14 days

Title

Evaluate the accuracy of the Free Style Libre for each day of use and during hyperglicemia ( >180 mg / dl )

Description

accuracy of freestyle Libre flash monitoring measured as MARD respect to blood glucose (YSI) during CRC visit and respect to glucometer during home setting,

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 18 years Diagnosis of diabetes mellitus type 1 ( diagnosed according to World Health Organization criteria ) for at least one year Body Mass Index ( BMI ) < 35 kg / m² Willingness to wear the device and to comply with the study protocol during the entire duration of the same No restrictions linked to glycated hemoglobin ( HbA1c ) Signature of informed consent before any study-related procedure Exclusion Criteria: Pregnancy, breast-feeding, planning pregnancy, or refuse to use contraception during the study period (for female subjects). Known allergies to patches or skin disinfectants used during the study. skin lesions, irritation, redness, edema, in the possible application of the sensor sites that may interfere with the placement of the device or the detection accuracy of test results. blood donations in the 3 months preceding the study. Use of drugs that can interfere with glucose metabolism (such as steroids) unless it is chronic therapies whose dosage has remained stable over the last 3 months and is expected to remain stable during the study period. serious medical or psychological conditions that in the opinion of the medical team could compromise patient safety during study participation. Patients enrolled in other clinical trials. known disorders of the adrenal glands, pancreatic tumors, or insulinomas Inability of the patient to comply with the study procedures

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daniela Bruttomesso, MD

Phone

+390498212183

daniela.bruttomesso@unipd.it

Facility Information:

Facility Name

University of Padova

City

Padova

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniela Bruttomesso, MD, PHD

daniela.bruttomesso@unipd.it

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29502924

Citation

Boscari F, Galasso S, Acciaroli G, Facchinetti A, Marescotti MC, Avogaro A, Bruttomesso D. Head-to-head comparison of the accuracy of Abbott FreeStyle Libre and Dexcom G5 mobile. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):425-427. doi: 10.1016/j.numecd.2018.01.003. Epub 2018 Jan 31. No abstract available.

Results Reference

derived

PubMed Identifier

29300991

Citation

Fadini GP, Boscari F, Cappellari R, Galasso S, Rigato M, Bonora BM, D'Anna M, Bruttomesso D, Avogaro A. Effects of Hypoglycemia on Circulating Stem and Progenitor Cells in Diabetic Patients. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1048-1055. doi: 10.1210/jc.2017-02187.

Results Reference

derived

PubMed Identifier

29258716

Citation

Boscari F, Galasso S, Facchinetti A, Marescotti MC, Vallone V, Amato AML, Avogaro A, Bruttomesso D. FreeStyle Libre and Dexcom G4 Platinum sensors: Accuracy comparisons during two weeks of home use and use during experimentally induced glucose excursions. Nutr Metab Cardiovasc Dis. 2018 Feb;28(2):180-186. doi: 10.1016/j.numecd.2017.10.023. Epub 2017 Nov 11.

Results Reference

derived

Learn more about this trial

Accuracy of Freestyle Libre

We'll reach out to this number within 24 hrs