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.

Performance of the Freestyle Libre flash glucose monitoring (flash GM) system in individuals with type 1 diabetes: A secondary outcome analysis of a randomized crossover trial

“…This is contrary to the findings of Aberer et al, who identified a mean absolute relative difference of 14.6% with the flash GM system . When comparing findings of our study to those concerning other CGM devices (iPro2, Enlite 2 and Minimed 640G, Medtronic), it appears that hypoglycaemia might be a challenge to the flash GM system . Additionally, during acute exercise accompanied by hypoglycaemia, flash GM data indicated a MARD of 45.1%; hence, glucose values must be interpreted very cautiously.…”

“…Freestyle Libre 1, Abbott, USA; Dexcom G4 Platinum, Dexcom, USA) CGM systems. [7][8][9] The performance of the flash GM system sensor was found to be accurate, with an overall mean absolute relative difference of approximately 13% under routine environmental conditions. 8 During acute glycaemic challenges such as physical exercise or following carbohydrate-rich meals and high doses of exogenous insulin, the interstitial glucose response may be further delayed.…”

“…From a physiological point of view, a time lag was observed in the interval needed for glucose to diffuse from the bloodstream into the interstitium . In general, use of CGM systems involves a struggle with sensor accuracy during hypoglycaemia and exercise, as shown for both professional (iPro2, Enlite 2, Medtronic, USA) and personal (Minimed 640G, Medtronic; Freestyle Libre 1, Abbott, USA; Dexcom G4 Platinum, Dexcom, USA) CGM systems . The performance of the flash GM system sensor was found to be accurate, with an overall mean absolute relative difference of approximately 13% under routine environmental conditions .…”

Glucose management for exercise using continuous glucose monitoring (CGM) and intermittently scanned CGM (isCGM) systems in type 1 diabetes: position statement of the European Association for the Study of Diabetes (EASD) and of the International Society for Pediatric and Adolescent Diabetes (ISPAD) endorsed by JDRF and supported by the American Diabetes Association (ADA)

“…Level of evidence was set according to the Memorandum of Understanding (MOU) between the European Association for the Study of Diabetes (EASD) and the writing group of this position statement. Levels of evidence are, thus, categorised as: (Ia) evidence from meta-analysis of randomised controlled trials; (Ib) evidence from at least one Aberer et al (2017a) [35] Giani et al (2018) [36] Moser et al (2019) [24] Moser et al (2019) [25] Aberer et al (2017b) [35] Bally et al (2016a) [37] Bally et al (2016b) [37] Breton et al (2017) [29] Larose et al (2019) [16] Li et al (2019) [27] Steineck et al (2019a) [17] Steineck et al (2019b) [17] Taleb et al (2016a) [28] Taleb et al (2016b) [28] Zaharieva et al (2019) [22] Aberer et al (2017c) [35] Biagi et al (2018a) [33] Biagi et al (2018b) [33] Gomez et al (2015a) [30] Gomez et al (2015b) [30] Jayawardene et al (2017a) [31] Jayawardene et al (2017b) [31] Moser et al (2016a) [18] Moser et al (2016b) [18] Moser et al (2016c) [18] Moser et al (2016d) [18] Moser et al (2016e) [18] Moser et al (2016f) [18] Moser et al (2019a) [34] Moser et al (2019b) [34] Taleb et al (2016c) [28] Taleb et al (2016d) [28] Zaharieva et al (2017a) [32] Zaharieva et al (2017b) […”

RT-CGM in adults with type 1 diabetes improves both glycaemic and patient-reported outcomes, but independent of each other

“…In contrast to some trial data [6], RT-CGM was not related to a lower number of severe hypoglycaemic events. Accuracy in the hypoglycaemic range remains an important weakness of most RT-CGM devices, certainly in the past [21].…”