F Boscari1, S Galasso1, A Facchinetti2, M C Marescotti1, V Vallone1, A M L Amato1, A Avogaro1, D Bruttomesso3. 1. Division of Metabolic Diseases, Department of Medicine, University of Padova, Padova, Italy. 2. Department of Informatics Engineering, University of Padova, Padova, Italy. 3. Division of Metabolic Diseases, Department of Medicine, University of Padova, Padova, Italy. Electronic address: daniela.bruttomesso@unipd.it.
Abstract
BACKGROUND AND AIMS: This study compared the accuracy of the FreeStyle Libre (Abbott, Alameda, CA) and Dexcom G4 Platinum (DG4P, Dexcom, San Diego, CA) CGM sensors. METHODS AND RESULTS:Twenty-two adults with type 1 diabetes wore the two sensors simultaneously for 2 weeks. Libre was used according to manufacturer-specified lifetime (MSL); DG4P was used 7 days beyond MSL. At a clinical research center (CRC), subjects were randomized to receive the same breakfast with standard insulin bolus (standard) or a delayed and increased (delayed & increased) bolus to induce large glucose swings during weeks 1 and 2; venous glucose was checked every 5-15 min for 6 h. Subjects performed ≥4 reference fingersticks/day at home. Accuracy was assessed by differences in mean absolute relative difference (%MARD) in glucose levels compared with fingerstick test (home use) and YSI reference (CRC). During home-stay the Libre MARD was 13.7 ± 3.6% and the DG4P MARD 12.9 ± 2.5% (difference not significant [NS]). With both systems MARD increased during hypoglycaemia and decreased during hyperglycaemia, without significant difference between sensors. In the euglycaemic range MARD was smaller with DG4P [12.0 ± 2.4% vs 14.0 ± 3.6%, p = 0.026]. MARD increased in both sensors following delayed & increased vs. standard bolus (Libre: 14.9 ± 5.5% vs. 10.9 ± 4.1%, p = 0.008; DG4P: 18.1 ± 8.1% vs. 13.1 ± 4.6%, p = 0.026); between-sensor differences were not significant (p = 0.062). Libre was more accurate during moderate and rapid glucose changes. CONCLUSIONS: DG4P and Libre performed similarly up to 7 days beyond DG4P MSL. Both sensors performed less well during hypoglycaemia but Libre was more accurate during glucose swings. TRIAL REGISTRATION: The study was registered in ClinicalTrials.gov (NCT02734745) April 12, 2016.
RCT Entities:
BACKGROUND AND AIMS: This study compared the accuracy of the FreeStyle Libre (Abbott, Alameda, CA) and Dexcom G4 Platinum (DG4P, Dexcom, San Diego, CA) CGM sensors. METHODS AND RESULTS: Twenty-two adults with type 1 diabetes wore the two sensors simultaneously for 2 weeks. Libre was used according to manufacturer-specified lifetime (MSL); DG4P was used 7 days beyond MSL. At a clinical research center (CRC), subjects were randomized to receive the same breakfast with standard insulin bolus (standard) or a delayed and increased (delayed & increased) bolus to induce large glucose swings during weeks 1 and 2; venous glucose was checked every 5-15 min for 6 h. Subjects performed ≥4 reference fingersticks/day at home. Accuracy was assessed by differences in mean absolute relative difference (%MARD) in glucose levels compared with fingerstick test (home use) and YSI reference (CRC). During home-stay the Libre MARD was 13.7 ± 3.6% and the DG4P MARD 12.9 ± 2.5% (difference not significant [NS]). With both systems MARD increased during hypoglycaemia and decreased during hyperglycaemia, without significant difference between sensors. In the euglycaemic range MARD was smaller with DG4P [12.0 ± 2.4% vs 14.0 ± 3.6%, p = 0.026]. MARD increased in both sensors following delayed & increased vs. standard bolus (Libre: 14.9 ± 5.5% vs. 10.9 ± 4.1%, p = 0.008; DG4P: 18.1 ± 8.1% vs. 13.1 ± 4.6%, p = 0.026); between-sensor differences were not significant (p = 0.062). Libre was more accurate during moderate and rapid glucose changes. CONCLUSIONS:DG4P and Libre performed similarly up to 7 days beyond DG4P MSL. Both sensors performed less well during hypoglycaemia but Libre was more accurate during glucose swings. TRIAL REGISTRATION: The study was registered in ClinicalTrials.gov (NCT02734745) April 12, 2016.
Authors: F Boscari; M D'Anna; B M Bonora; S Tresso; R Cappellari; A Avogaro; D Bruttomesso; G P Fadini Journal: J Endocrinol Invest Date: 2020-05-04 Impact factor: 4.256
Authors: Carolina B Lobato; Sofia S Pereira; Marta Guimarães; Tiago Morais; Pedro Oliveira; Jorge P M de Carvalho; Mário Nora; Mariana P Monteiro Journal: Sci Rep Date: 2020-07-06 Impact factor: 4.379
Authors: Odd Martin Staal; Heidi Marie Umbach Hansen; Sverre Christian Christiansen; Anders Lyngvi Fougner; Sven Magnus Carlsen; Øyvind Stavdahl Journal: Biosensors (Basel) Date: 2018-10-17