Accuracy of continuous glucose monitoring in patients after total pancreatectomy with islet autotransplantation

Gregory P. Forlenza, Brandon M Nathan, Antoinette Moran, Ty B Dunn, Gregory J Beilman, Timothy L Pruett, Boris P. Kovatchev, Melena D Bellin

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6 Citations (Scopus)

Abstract

Background: Among postsurgical and critically ill patients, malglycemia is associated with increased complications. Continuous glucose monitoring (CGM) in the inpatient population may enhance glycemic control. CGM reliability may be compromised by postsurgical complications such as edema or vascular changes. We utilized Clarke Error Grid (CEG) and Surveillance Error Grid (SEG) analysis to evaluate CGM performance after total pancreatectomy with islet autotransplantation. Materials and Methods: This subanalysis evaluated Medtronic Enlite 2 CGM values against YSI serum glucose in seven post-transplant patients (86% female; 38.6 ± 9.4 years) on artificial pancreas for 72 h at transition from intravenous to subcutaneous insulin. Sensor recalibration occurred for absolute relative difference (ARD) ≥20% x2, ≥30% x1, or by investigator discretion based on trend. Results: Sensor analysis showed mean absolute relative difference (MARD) of 11.0% ± 11.5%. The sensors were recalibrated 8.3 times/day; active sensor was switched 1.4 times/day. Calibration factor was 7.692 ± 3.786 mg/nA·dL (target = 1.5-20 mg/nA·dL). CEG analysis showed 86.1% of pairs in Zone A (clinically accurate zone) and 99.4% of pairs in Zones A + B (low risk of error). SEG analysis of hypoglycemia/hyperglycemia risk showed 92.22% of pairs in the "no risk" zone, 5.96% of pairs in the "slight lower" risk zone, 1.01% of pairs in the "slight higher" risk zone, and only 0.81% of pairs in the "moderate lower" risk zone. Conclusions: Overall performance of the Medtronic Enlite 2 CGM in the post-transplant population was reasonably good with "no risk" or "slight lower" risk by SEG analysis and high CGM-YSI agreement by CEG analysis; however, frequent recalibrations were required in this intensive care population.

Original languageEnglish (US)
Pages (from-to)455-463
Number of pages9
JournalDiabetes Technology and Therapeutics
Volume18
Issue number8
DOIs
StatePublished - Aug 1 2016

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Pancreatectomy
Autologous Transplantation
Physiologic Monitoring
Glucose
Artificial Pancreas
Population
Transplants
Critical Care
Hypoglycemia
Critical Illness
Hyperglycemia
Calibration
Blood Vessels
Inpatients
Edema
Research Personnel
Insulin
Serum

Cite this

@article{4f846b5c09244d1e9cdb7c64c3f20f6f,
title = "Accuracy of continuous glucose monitoring in patients after total pancreatectomy with islet autotransplantation",
abstract = "Background: Among postsurgical and critically ill patients, malglycemia is associated with increased complications. Continuous glucose monitoring (CGM) in the inpatient population may enhance glycemic control. CGM reliability may be compromised by postsurgical complications such as edema or vascular changes. We utilized Clarke Error Grid (CEG) and Surveillance Error Grid (SEG) analysis to evaluate CGM performance after total pancreatectomy with islet autotransplantation. Materials and Methods: This subanalysis evaluated Medtronic Enlite 2 CGM values against YSI serum glucose in seven post-transplant patients (86{\%} female; 38.6 ± 9.4 years) on artificial pancreas for 72 h at transition from intravenous to subcutaneous insulin. Sensor recalibration occurred for absolute relative difference (ARD) ≥20{\%} x2, ≥30{\%} x1, or by investigator discretion based on trend. Results: Sensor analysis showed mean absolute relative difference (MARD) of 11.0{\%} ± 11.5{\%}. The sensors were recalibrated 8.3 times/day; active sensor was switched 1.4 times/day. Calibration factor was 7.692 ± 3.786 mg/nA·dL (target = 1.5-20 mg/nA·dL). CEG analysis showed 86.1{\%} of pairs in Zone A (clinically accurate zone) and 99.4{\%} of pairs in Zones A + B (low risk of error). SEG analysis of hypoglycemia/hyperglycemia risk showed 92.22{\%} of pairs in the {"}no risk{"} zone, 5.96{\%} of pairs in the {"}slight lower{"} risk zone, 1.01{\%} of pairs in the {"}slight higher{"} risk zone, and only 0.81{\%} of pairs in the {"}moderate lower{"} risk zone. Conclusions: Overall performance of the Medtronic Enlite 2 CGM in the post-transplant population was reasonably good with {"}no risk{"} or {"}slight lower{"} risk by SEG analysis and high CGM-YSI agreement by CEG analysis; however, frequent recalibrations were required in this intensive care population.",
author = "Forlenza, {Gregory P.} and Nathan, {Brandon M} and Antoinette Moran and Dunn, {Ty B} and Beilman, {Gregory J} and Pruett, {Timothy L} and Kovatchev, {Boris P.} and Bellin, {Melena D}",
year = "2016",
month = "8",
day = "1",
doi = "10.1089/dia.2015.0405",
language = "English (US)",
volume = "18",
pages = "455--463",
journal = "Diabetes Technology and Therapeutics",
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TY - JOUR

T1 - Accuracy of continuous glucose monitoring in patients after total pancreatectomy with islet autotransplantation

AU - Forlenza, Gregory P.

AU - Nathan, Brandon M

AU - Moran, Antoinette

AU - Dunn, Ty B

AU - Beilman, Gregory J

AU - Pruett, Timothy L

AU - Kovatchev, Boris P.

AU - Bellin, Melena D

PY - 2016/8/1

Y1 - 2016/8/1

N2 - Background: Among postsurgical and critically ill patients, malglycemia is associated with increased complications. Continuous glucose monitoring (CGM) in the inpatient population may enhance glycemic control. CGM reliability may be compromised by postsurgical complications such as edema or vascular changes. We utilized Clarke Error Grid (CEG) and Surveillance Error Grid (SEG) analysis to evaluate CGM performance after total pancreatectomy with islet autotransplantation. Materials and Methods: This subanalysis evaluated Medtronic Enlite 2 CGM values against YSI serum glucose in seven post-transplant patients (86% female; 38.6 ± 9.4 years) on artificial pancreas for 72 h at transition from intravenous to subcutaneous insulin. Sensor recalibration occurred for absolute relative difference (ARD) ≥20% x2, ≥30% x1, or by investigator discretion based on trend. Results: Sensor analysis showed mean absolute relative difference (MARD) of 11.0% ± 11.5%. The sensors were recalibrated 8.3 times/day; active sensor was switched 1.4 times/day. Calibration factor was 7.692 ± 3.786 mg/nA·dL (target = 1.5-20 mg/nA·dL). CEG analysis showed 86.1% of pairs in Zone A (clinically accurate zone) and 99.4% of pairs in Zones A + B (low risk of error). SEG analysis of hypoglycemia/hyperglycemia risk showed 92.22% of pairs in the "no risk" zone, 5.96% of pairs in the "slight lower" risk zone, 1.01% of pairs in the "slight higher" risk zone, and only 0.81% of pairs in the "moderate lower" risk zone. Conclusions: Overall performance of the Medtronic Enlite 2 CGM in the post-transplant population was reasonably good with "no risk" or "slight lower" risk by SEG analysis and high CGM-YSI agreement by CEG analysis; however, frequent recalibrations were required in this intensive care population.

AB - Background: Among postsurgical and critically ill patients, malglycemia is associated with increased complications. Continuous glucose monitoring (CGM) in the inpatient population may enhance glycemic control. CGM reliability may be compromised by postsurgical complications such as edema or vascular changes. We utilized Clarke Error Grid (CEG) and Surveillance Error Grid (SEG) analysis to evaluate CGM performance after total pancreatectomy with islet autotransplantation. Materials and Methods: This subanalysis evaluated Medtronic Enlite 2 CGM values against YSI serum glucose in seven post-transplant patients (86% female; 38.6 ± 9.4 years) on artificial pancreas for 72 h at transition from intravenous to subcutaneous insulin. Sensor recalibration occurred for absolute relative difference (ARD) ≥20% x2, ≥30% x1, or by investigator discretion based on trend. Results: Sensor analysis showed mean absolute relative difference (MARD) of 11.0% ± 11.5%. The sensors were recalibrated 8.3 times/day; active sensor was switched 1.4 times/day. Calibration factor was 7.692 ± 3.786 mg/nA·dL (target = 1.5-20 mg/nA·dL). CEG analysis showed 86.1% of pairs in Zone A (clinically accurate zone) and 99.4% of pairs in Zones A + B (low risk of error). SEG analysis of hypoglycemia/hyperglycemia risk showed 92.22% of pairs in the "no risk" zone, 5.96% of pairs in the "slight lower" risk zone, 1.01% of pairs in the "slight higher" risk zone, and only 0.81% of pairs in the "moderate lower" risk zone. Conclusions: Overall performance of the Medtronic Enlite 2 CGM in the post-transplant population was reasonably good with "no risk" or "slight lower" risk by SEG analysis and high CGM-YSI agreement by CEG analysis; however, frequent recalibrations were required in this intensive care population.

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