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

• Published in: Journal of diabetes science and technology Vol. 11; no. 6; pp. 1147 - 1154
• Main Authors: Faccioli, Simone, Del Favero, Simone, Visentin, Roberto, Bonfanti, Riccardo, Iafusco, Dario, Rabbone, Ivana, Marigliano, Marco, Schiaffini, Riccardo, Bruttomesso, Daniela, Cobelli, Claudio
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.11.2017
• Subjects: Abdomen; Algorithms; Analysis of Variance; Arm; Biomarkers - blood; Blood Glucose - drug effects; Blood Glucose - metabolism; Blood Glucose Self-Monitoring - instrumentation; Buttocks; Child; Child, Preschool; Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - diagnosis; Diabetes Mellitus, Type 1 - drug therapy; Equipment Design; Female; Humans; Hypoglycemic Agents - administration & dosage; Insulin - administration & dosage; Insulin Infusion Systems; Male; Monitoring, Ambulatory - instrumentation; Original; Predictive Value of Tests; Reproducibility of Results; Signal Processing, Computer-Assisted; Transducers; type 1 diabetes; accuracy evaluation; continuous glucose monitoring; insertion sites; pediatric
• ISSN: 1932-2968; 1932-3107; 1932-3107
• DOI: 10.1177/1932296817706377

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.