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Discrepancies between methods of continuous glucose monitoring in key metrics of glucose control in children with type 1 diabetes

Byline: Arkadiusz Michalak, Konrad Pagacz, Wojciech MAynarski, Agnieszka Szadkowska,Wojciech Fendler Keywords: continuous glucose monitoring; flash glucose monitoring; glycemic variability; type 1 diabetes Abstract Objective We aimed to compare glycemic control and variability parameters obtained fr... Full description

Journal Title: Pediatric Diabetes August 2019, Vol.20(5), pp.604-612
Main Author: Michalak, Arkadiusz
Other Authors: Pagacz, Konrad , Młynarski, Wojciech , Szadkowska, Agnieszka , Fendler, Wojciech
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ID: ISSN: 1399-543X ; E-ISSN: 1399-5448 ; DOI: 10.1111/pedi.12854
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title: Discrepancies between methods of continuous glucose monitoring in key metrics of glucose control in children with type 1 diabetes
format: Article
creator:
  • Michalak, Arkadiusz
  • Pagacz, Konrad
  • Młynarski, Wojciech
  • Szadkowska, Agnieszka
  • Fendler, Wojciech
subjects:
  • Continuous Glucose Monitoring
  • Flash Glucose Monitoring
  • Glycemic Variability
  • Type 1 Diabetes
ispartof: Pediatric Diabetes, August 2019, Vol.20(5), pp.604-612
description: Byline: Arkadiusz Michalak, Konrad Pagacz, Wojciech MAynarski, Agnieszka Szadkowska,Wojciech Fendler Keywords: continuous glucose monitoring; flash glucose monitoring; glycemic variability; type 1 diabetes Abstract Objective We aimed to compare glycemic control and variability parameters obtained from paired records of real-time continuous glucose monitoring (RT-CGM) and flash glucose monitoring (FGM). Methods Ten Polish boys and 11 girls aged 15.3[+ or -]2.1years with type 1 diabetes for 7.7[+ or -]4.5years and glycated hemoglobin 7.35[+ or -]0.7% (57[+ or -]5 mmol/mol) were recruited between August 2017 and June 2018 and equipped with devices for RT-CGM (iPro2 system with Enlite electrodes) and FGM (FreeStyle Libre) for 1 week. Afterwards, Glyculator 2.0 software was used to calculate and compare key metrics of glycemic control listed in the International Consensus on Use of Continuous Glucose Monitoring, with distinction into all record/night-time/day-time blocks when appropriate. Results Agreement between the two systems' measurements across patients ranged from poor (R.sup.2=.39) to nearly perfect (R.sup.2=.97). Significant differences between RT-CGM and FGM were observed in five important metrics: coefficient of variation (median difference: -4.12% [25%-75%: -7.50% to -2.96%], P=.0001), low blood glucose index (-0.88 [-1.88 to -0.18], P=.0004), % of time below 70mg/dL (3.9 mmol/L) (-4.77 [-8.39 to -1.19], P=.0015) and 54mg/dL (3 mmol/L) (-1.33 [-4.07 to 0.00], P=.0033) and primary time in range (TIR) 70-180mg/dL (8.58 [1.31 to 12.66], P=.0006). Conclusions RT-CGM and FGM differ in their estimates of clinically important indices of glycemic control. Therefore, such metrics cannot be directly compared between people using different systems. Our result necessitates system-specific guidelines and targets if TIR and glycemic variability are to be used as an endpoint in clinical trials. Article Note: Arkadiusz Michalak, Konrad Pagacz, Agnieszka Szadkowska and Wojciech Fendler contributed equally to this study. Funding information Uniwersytet Medyczny w Lodzi, Grant/Award Number: 564/1-000-00/564-20-019 CAPTION(S): Figure S1. Flowchart of the study course. In summary, 28 patients agreed to take part in the study and 7 (25%) either dropped out during the study or were excluded from analysis. Table S1. Complete comparison of FGM- and RT-CGM-derived glucose indexes based on nighttime records of the study participants. The differences were calculated by subtrac
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identifier: ISSN: 1399-543X ; E-ISSN: 1399-5448 ; DOI: 10.1111/pedi.12854
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issn:
  • 1399-543X
  • 1399543X
  • 1399-5448
  • 13995448
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titleDiscrepancies between methods of continuous glucose monitoring in key metrics of glucose control in children with type 1 diabetes
creatorMichalak, Arkadiusz ; Pagacz, Konrad ; Młynarski, Wojciech ; Szadkowska, Agnieszka ; Fendler, Wojciech
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descriptionByline: Arkadiusz Michalak, Konrad Pagacz, Wojciech MAynarski, Agnieszka Szadkowska,Wojciech Fendler Keywords: continuous glucose monitoring; flash glucose monitoring; glycemic variability; type 1 diabetes Abstract Objective We aimed to compare glycemic control and variability parameters obtained from paired records of real-time continuous glucose monitoring (RT-CGM) and flash glucose monitoring (FGM). Methods Ten Polish boys and 11 girls aged 15.3[+ or -]2.1years with type 1 diabetes for 7.7[+ or -]4.5years and glycated hemoglobin 7.35[+ or -]0.7% (57[+ or -]5 mmol/mol) were recruited between August 2017 and June 2018 and equipped with devices for RT-CGM (iPro2 system with Enlite electrodes) and FGM (FreeStyle Libre) for 1 week. Afterwards, Glyculator 2.0 software was used to calculate and compare key metrics of glycemic control listed in the International Consensus on Use of Continuous Glucose Monitoring, with distinction into all record/night-time/day-time blocks when appropriate. Results Agreement between the two systems' measurements across patients ranged from poor (R.sup.2=.39) to nearly perfect (R.sup.2=.97). Significant differences between RT-CGM and FGM were observed in five important metrics: coefficient of variation (median difference: -4.12% [25%-75%: -7.50% to -2.96%], P=.0001), low blood glucose index (-0.88 [-1.88 to -0.18], P=.0004), % of time below 70mg/dL (3.9 mmol/L) (-4.77 [-8.39 to -1.19], P=.0015) and 54mg/dL (3 mmol/L) (-1.33 [-4.07 to 0.00], P=.0033) and primary time in range (TIR) 70-180mg/dL (8.58 [1.31 to 12.66], P=.0006). Conclusions RT-CGM and FGM differ in their estimates of clinically important indices of glycemic control. Therefore, such metrics cannot be directly compared between people using different systems. Our result necessitates system-specific guidelines and targets if TIR and glycemic variability are to be used as an endpoint in clinical trials. Article Note: Arkadiusz Michalak, Konrad Pagacz, Agnieszka Szadkowska and Wojciech Fendler contributed equally to this study. Funding information Uniwersytet Medyczny w Lodzi, Grant/Award Number: 564/1-000-00/564-20-019 CAPTION(S): Figure S1. Flowchart of the study course. In summary, 28 patients agreed to take part in the study and 7 (25%) either dropped out during the study or were excluded from analysis. Table S1. Complete comparison of FGM- and RT-CGM-derived glucose indexes based on nighttime records of the study participants. The differences were calculated by subtracting FGM from RT-CGM estimates. All values are expressed as median (25%-75% range), assigned P-values were calculated with Wilcoxon's paired ranked test. Corresponding q-values were obtained for each comparison by adjusting the P-values to the whole number of performed comparisons in all time-blocks (n=92) using Benjamini-Hochberg procedure and fixing false discovery rate as 0.05. Differences that reached q-values <.05 are considered significant. Table S2. Complete comparison of FGM- and RT-CGM-derived glucose indexes based on daytime records of the study participants. The differences were calculated by subtracting FGM from RT-CGM estimates. All values are expressed as median (25%-75% range), assigned P-values were calculated with Wilcoxon's paired ranked test. Corresponding q-values were obtained for each comparison by adjusting the P-values to the whole number of performed comparisons in all time-blocks (n=92) using Benjamini-Hochberg procedure and fixing false discovery rate as .05. Differences that reached q-values <.05 are considered significant. Table S3. Glycemic variability indices and their short explanation.
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