Performance of intermittently scanned continuous glucose monitoring systems in people with type 1 diabetes: A pooled analysis

Abstract

Aims: To conduct a pooled analysis to assess the performance of intermittently scanned continuous glucose monitoring (isCGM) in association with the rate of change in sensor glucose in a cohort of children, adolescents, and adults with type 1 diabetes. Material and Methods:In this pooled analysis, isCGM system accuracy was assessed depending on the rate of change in sensor glucose. Clinical studies that have been investigating isCGM accuracy against blood glucose, accompanied with collection time points were included in this analysis. isCGM performance was assessed by means of median absolute relative difference (MedARD), Parkes error grid (PEG) and Bland-Altman plot analyses.Results: Twelve studies comprising 311 participants were included, with a total of 15 837 paired measurements. The overall MedARD (interquartile range) was 12.7% (5.9-23.5) and MedARD differed significantly based on the rate of change in glucose (P < 0.001). An absolute difference of À22 mg/dL (À1.2 mmol/L) (95% limits of agreement [LoA] 60 mg/dL (3.3 mmol/L), À103 mg/dL (À5.7 mmol/L)) was found when glucose was rapidly increasing (isCGM glucose minus reference blood glucose), while a À32 mg/dL (1.8 mmol/L) (95% LoA 116 mg/dL (6.4 mmol/L), À51 mg/dL (À2.8 mmol/ L)) absolute difference was observed in periods of rapidly decreasing glucose. Conclusions:The performance of isCGM was good when compared to reference blood glucose measurements. The rate of change in glucose for both increasing and Othmar Moser and Christoph Sternad share the first authorship.

Analytical Performance of the Factory-Calibrated Flash Glucose Monitoring System FreeStyle Libre2TM in Healthy Women

“…At least one study has observed differences in glycaemic variables assessed by CGM between normoglycemic individuals and people with impaired glucose tolerance [18], showing higher daytime average interstitial glucose concentrations and higher postprandial peaks in a group with abnormal glucose tolerance. In addition, studies examining the accuracy of CGM systems compared with glucose measurements from venous blood have provided inconsistent findings [1,15]. Therefore, the present study compared glucose responses assessed using the FreeStyle Libre2 TM CGM sensor with those obtained from venous plasma samples to investigate the accuracy of the sensor and its suitability for research purposes in healthy women.…”

“…The FreeStyle Libre TM CGM system is also commonly used for both clinical and research applications [8,[14][15][16]. The FreeStyle Libre TM sensors are factory-calibrated, which reduces the likelihood of inaccuracies compared to user-calibrated devices such as the Medtronic ENLiTE and Dexcom.…”

Use of Continuous Glucose Monitors by People Without Diabetes: An Idea Whose Time Has Come?

“…At the high end of the target range for most people (70-180 mg/dl) measured by CGMs, most of these products on the market function at approximately their published levels of accuracy, but at the low end of the target range, they are usually less accurate. 76 Several questions are currently unanswered (Table 2). With further research, it is hoped that the indications, benefits, and drawbacks of CGM for people without diabetes will become clearer.…”

Patent analysis of digital sensors for continuous glucose monitoring

“…The clinical accuracy of continuous glucose monitoring in patients with DM1 is shown in systematic reviews of randomized trials and meta-analyses by Teo et al, Moser et al, and Elbalshy et al (9)(10)(11). It is emphasized that future research should assess the precision and efficiency of CGM for various age groups and insulin therapy regimens.…”