Simone Faccioli1, Simone Del Favero1, Roberto Visentin1, Riccardo Bonfanti2, Dario Iafusco3, Ivana Rabbone4, Marco Marigliano5, Riccardo Schiaffini6, Daniela Bruttomesso7, Claudio Cobelli1. 1. 1 Department of Information Engineering, University of Padua, Padua, Italy. 2. 2 Diabetologia Pediatrica e Diabetes Research Institute (OSR-DRI), Ospedale San Raffaele, Milan, Italy. 3. 3 Department of Pediatrics, Second University of Naples, Naples, Italy. 4. 4 Department of Pediatrics, University of Turin, Turin, Italy. 5. 5 Regional Center for Pediatric Diabetes, Pediatric Diabetes and Metabolic Disorders Unit, Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy. 6. 6 Unit of Endocrinology and Diabetes, Bambino Gesù, Children's Hospital, Rome, Italy. 7. 7 Unit of Metabolic Diseases, Department of Internal Medicine-DIMED, University of Padua, Padua, Italy.
Abstract
BACKGROUND: Patients with diabetes, especially pediatric ones, sometimes use continuous glucose monitoring (CGM) sensor in different positions from the approved ones. Here we compare the accuracy of Dexcom® G5 CGM sensor in three different sites: abdomen, gluteus (both approved) and arm (off-label). METHOD: Thirty youths, 5-9 years old, with type 1 diabetes (T1D) wore the sensor during a clinical trial where frequent self-monitoring of blood glucose (SMBG) measurements were obtained. Sensor was inserted in different sites according to the patient habit. Accuracy metrics include absolute relative difference (ARD) and absolute difference (AD) of CGM with respect to SMBG. The three sites were compared with ANOVA. If the test detected a difference, an additional pair-wise comparison was performed. RESULTS: Overall, no accuracy difference was detected: the mean ARD was 13.3% (SD = 13.5%) for abdomen, 13.4% (12.9%) for arm and 12.9% (20.2%) for gluteus ( P value = .83); the mean AD was 17.0 mg/dl (17.2 mg/dl) for abdomen, 17.2 mg/dl (17.1 mg/dl) for arm and 18.3 mg/dl (18.5 mg/dl) for gluteus ( P value = .30). In hypo- and euglycemia ARD ( P value = .87 and .15, respectively), and AD ( P value = .68 and .37, respectively) were not statistically different. At variance, in hyperglycemia, a significant difference was detected between the two approved sites, abdomen and gluteus (ΔARD = -2.2% [CI = -4.2%, -0.1%], P value = .04), whereas the comparisons with the off-label location, arm-abdomen, and arm-gluteus were not significant. CONCLUSIONS: These results suggest that the accuracy of the sensor placed on the arm was not significantly different with respect to the two approved insertion sites (abdomen and gluteus). Larger, randomized trials are needed to draw final conclusions.
BACKGROUND:Patients with diabetes, especially pediatric ones, sometimes use continuous glucose monitoring (CGM) sensor in different positions from the approved ones. Here we compare the accuracy of Dexcom® G5 CGM sensor in three different sites: abdomen, gluteus (both approved) and arm (off-label). METHOD: Thirty youths, 5-9 years old, with type 1 diabetes (T1D) wore the sensor during a clinical trial where frequent self-monitoring of blood glucose (SMBG) measurements were obtained. Sensor was inserted in different sites according to the patient habit. Accuracy metrics include absolute relative difference (ARD) and absolute difference (AD) of CGM with respect to SMBG. The three sites were compared with ANOVA. If the test detected a difference, an additional pair-wise comparison was performed. RESULTS: Overall, no accuracy difference was detected: the mean ARD was 13.3% (SD = 13.5%) for abdomen, 13.4% (12.9%) for arm and 12.9% (20.2%) for gluteus ( P value = .83); the mean AD was 17.0 mg/dl (17.2 mg/dl) for abdomen, 17.2 mg/dl (17.1 mg/dl) for arm and 18.3 mg/dl (18.5 mg/dl) for gluteus ( P value = .30). In hypo- and euglycemia ARD ( P value = .87 and .15, respectively), and AD ( P value = .68 and .37, respectively) were not statistically different. At variance, in hyperglycemia, a significant difference was detected between the two approved sites, abdomen and gluteus (ΔARD = -2.2% [CI = -4.2%, -0.1%], P value = .04), whereas the comparisons with the off-label location, arm-abdomen, and arm-gluteus were not significant. CONCLUSIONS: These results suggest that the accuracy of the sensor placed on the arm was not significantly different with respect to the two approved insertion sites (abdomen and gluteus). Larger, randomized trials are needed to draw final conclusions.
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