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Accuracy of a CGM Sensor in Pediatric Subjects With Type 1 Diabetes. Comparison of Three Insertion Sites: Arm, Abdomen, and Gluteus

Authors :
Riccardo Schiaffini
Roberto Visentin
Ivana Rabbone
Riccardo Bonfanti
Dario Iafusco
Simone Del Favero
Claudio Cobelli
Simone Faccioli
Marco Marigliano
Daniela Bruttomesso
Faccioli, S.
Del Favero, S.
Visentin, R.
Bonfanti, R.
Iafusco, D.
Rabbone, I.
Marigliano, M.
Schiaffini, R.
Bruttomesso, D.
Cobelli, C.
Faccioli, Simone
Del Favero, Simone
Visentin, Roberto
Bonfanti, Riccardo
Iafusco, Dario
Rabbone, Ivana
Marigliano, Marco
Schiaffini, Riccardo
Bruttomesso, Daniela
Cobelli, Claudio
Publication Year :
2017
Publisher :
SAGE Publications Inc., 2017.

Abstract

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). 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.

Details

Language :
English
Database :
OpenAIRE
Accession number :
edsair.doi.dedup.....577a3a8a4f8c0587e930f99f27dd7610