Accuracy of Freestyle Libre

Diabetes Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02734745
• Other study ID #: 3724/AO/16
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2016
• Last updated: October 3, 2017
• Start date: April 1, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: April 2017
• Source: University of Padova
• Contact: Daniela Bruttomesso, MD
• Phone: +390498212183
• Email: daniela.bruttomesso[@]unipd.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetes Type 1

Intervention

Device:
• flash glucose monitoring
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.

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	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	14 days
Secondary	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	14 days
Secondary	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,	14 days
Secondary	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,	14 days