A head-to-head comparison of personal and professional continuous glucose monitoring systems in people with type 1 diabetes: Hypoglycaemia remains the weak spot

Abstract

To compare the performance of a professional continuous glucose monitoring (proCGM) and a personal continuous glucose monitoring (persCGM) system worn in parallel under standardized conditions in individuals with type 1 diabetes (T1D), two CGM systems (iPro2 - proCGM; Minimed 640G - persCGM) worn in parallel using the same sensor (Enlite 2) were compared. Ten people with T1D were included in this single-centre, open-label study in which CGM performance was evaluated. The study consisted of a 24-hours inpatient phase (meals, exercise, glycaemic challenges) and a 4-day home phase. Analyses included fulfilment of ISO 15197:2013 criteria, mean absolute relative difference (MARD), Parkes Error Grid and Bland-Altman plots. During the inpatient stay, ISO 15197:2013 criteria fulfilment was 58.4% (proCGM) and 57.8% (persCGM). At home, the systems met ISO 15197:2013 criteria by 66.5% (proCGM) and 65.3% (persCGM). No difference of MARD in inpatient phase (19.1 ± 16.7% vs. 19.0 ± 19.6; P = 0.83) and home phase (18.6 ± 26.8% vs. 17.4 ± 21.3%, P = 0.87) was observed. All sensors performed less accurately during hypoglycaemia. ProCGM and persCGM showed similar performance during daytime and night-time for the inpatient and the home phase. However, sensor performance was reduced during hypoglycaemia for both systems.

Keywords: clinical trial; continuous glucose monitoring (CGM); hypoglycaemia; type 1 diabetes.

Figure 1

PEG analysis for proCGM during: A, inpatient phase daytime (zone A: 65.34%, zone B: 33.13%, zone C: 1.53%); B, inpatient phase night‐time (zone A: 80.36%, zone B: 19.64 %); C, persCGM during inpatient phase daytime (zone A: 65.84%, zone B: 30.74%, zone C: 2.85%, zone D: 0.57%); D, inpatient phase night‐time (zone A: 78.95%, zone B: 21.05%); E, proCGM during home phase daytime (zone A: 75.85%, zone B: 19.32%, zone C: 3.86%, zone D: 0.97%); F, home phase night‐time (zone A: 79.73%, zone B: 17.57%, zone C: 2.70%); G, persCGM during home phase daytime (zone A: 81.02%, zone B: 16.42%, zone C: 2.19%, zone D: 0.36%); and H, home phase night‐time (zone A: 71.56%, zone B: 26.61%, zone C: 1.83%)