Aims: To assess the accuracy and reliability of the two most widely used continuous glucose monitoring (CGM) systems. Methods: We studied the Dexcom (R) G4 Platinum (DG4P; Dexcom, San Diego, CA, USA) and Medtronic Paradigm Veo Enlite system (ENL; Medtronic, Northridge, CA, USA) CGM systems, in 24 patients with type 1 diabetes. The CGM systems were tested during 6-day home use and a nested 6-h clinical research centre (CRC) visit. During the CRC visit, frequent venous blood glucose samples were used as reference while patients received a meal with an increased insulin bolus to induce an aggravated postprandial glucose nadir. At home, patients performed at least six reference capillary blood measurements per day. A Wilcoxon signed-rank test was performed using all data points >= 15 min apart. Results: The overall mean absolute relative difference (MARD) value [standard deviation (s.d.)] measured at the CRC was 13.6 (11.0)% for the DG4P and 16.6 (13.5)% for the ENL [p<0.0002, confidence interval of difference (CI Delta) 1.7-4.3%, n=530]. The overall MARD assessed at home was 12.2 (12.0)% for the DG4P and 19.9 (20.5)% for the ENL (p<0.0001, CI Delta=5.8-8.7%, n=839). During the CRC visit, the MARD in the hypoglycaemic range [<= 3.9 mmol/l (70mg/dl)], was 17.6 (12.2)% for the DG4P and 24.6 (18.8)% for the ENL (p=0.005, CI Delta 3.1-10.7%, n=117). Both sensors showed higher MARD values during hypoglycaemia than during euglycaemia [3.9-10 mmol/l (70-180 mg/dl)]: for the DG4P 17.6 versus 13.0% and for the ENL 24.6 versus 14.2%. Conclusions: During circumstances of intended use, including both a CRC and home phase, the ENL was noticeably less accurate than the DG4P sensor. Both sensors showed lower accuracy in the hypoglycaemic range. The DG4P was less affected by this negative effect of hypoglycaemia on sensor accuracy than was the ENL.
机构:
Univ Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
ASST Santi Paolo & Carlo, Otolaryngol Unit, Via Rudini 8, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Sighinolfi, Maria C.
Rocco, Bernardo
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Univ Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Rocco, Bernardo
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Terzoni, Stefano
Morandi, Alessandro
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Univ Milan, Gynecol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Morandi, Alessandro
Afonina, Margarita
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Univ Milan, Gynecol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Afonina, Margarita
Assumma, Simone
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Univ Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Assumma, Simone
Calcagnile, Tommaso
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Univ Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Calcagnile, Tommaso
Turri, Filippo
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Univ Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Turri, Filippo
Sangalli, Mattia
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Univ Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Sangalli, Mattia
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Panio, Enrico
Sarchi, Luca
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Univ Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Sarchi, Luca
Grasso, Angelica
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Univ Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Grasso, Angelica
Dell'orto, Paolo
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Univ Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Dell'orto, Paolo
Pozzi, Efrem
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Univ Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Pozzi, Efrem
Ramondo, Augusto
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Univ Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Ramondo, Augusto
Santangelo, Emanuela
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Univ Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Santangelo, Emanuela
Petix, Michele
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Univ Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
Petix, Michele
Gaia, Giorgia
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Univ Milan, Gynecol Unit, ASST Santi Paolo & Carlo, Milan, ItalyUniv Milan, Urol Unit, ASST Santi Paolo & Carlo, Milan, Italy
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Univ Virginia Sch Med, Dept Pediat Psychiat Med & Internal Med, Div Pediat Endocrinol Computat Neurosci, Charlottesville, VA 22908 USA
Univ Virginia, Sch Med, Dept Pediat Psychiat Med & Internal Med, Div Adult Endocrinol, Charlottesville, VA 22908 USAUniv Virginia Sch Med, Dept Pediat Psychiat Med & Internal Med, Div Pediat Endocrinol Computat Neurosci, Charlottesville, VA 22908 USA
Clarke, William L.
Anderson, Stacey
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Univ Virginia Sch Med, Dept Pediat Psychiat Med & Internal Med, Div Pediat Endocrinol Computat Neurosci, Charlottesville, VA 22908 USA
Univ Virginia, Sch Med, Dept Pediat Psychiat Med & Internal Med, Div Adult Endocrinol, Charlottesville, VA 22908 USAUniv Virginia Sch Med, Dept Pediat Psychiat Med & Internal Med, Div Pediat Endocrinol Computat Neurosci, Charlottesville, VA 22908 USA
Anderson, Stacey
Kovatchev, Boris
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Univ Virginia Sch Med, Dept Pediat Psychiat Med & Internal Med, Div Pediat Endocrinol Computat Neurosci, Charlottesville, VA 22908 USA
Univ Virginia, Sch Med, Dept Pediat Psychiat Med & Internal Med, Div Adult Endocrinol, Charlottesville, VA 22908 USAUniv Virginia Sch Med, Dept Pediat Psychiat Med & Internal Med, Div Pediat Endocrinol Computat Neurosci, Charlottesville, VA 22908 USA