Accuracy of Freestyle Libre

NCT02734745 | Unknown

• 1 other identifier: 3724/AO/16
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 1

Keywords

diabetes type 1; flash glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  14 days

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

  14 days

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

  14 days

Study Arms (1)

flash glucose monitoring

EXPERIMENTAL

Patients will use a device: Freestyle Libre for 14 days

Device: flash glucose monitoring

Interventions

flash glucose monitoring DEVICE

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.

flash glucose monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University of Padova

Padua, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 29502924 DERIVED

• 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.

  PMID: 29300991 DERIVED

• 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.

  PMID: 29258716 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Daniela Bruttomesso, MD

CONTACT

+390498212183; daniela.bruttomesso@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 12, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)