title: Evaluation of subcutaneous glucose monitoring systems under routine environmental conditions in patients with type 1 diabetes.
abstract: Continuous and flash glucose monitoring (GM) systems have been established in diabetes care. We compared the sensor performance of 3 commercially available GM systems. A total of 12 patients with type 1 diabetes were included in a single-centre, open-label study in which the sensor performance of the Abbott FreeStyle libre (Abbott), Dexcom G4 Platinum (Dexcom) and Medtronic MiniMed 640G (Medtronic) systems over 12 hours was compared during mimicked real-life conditions (meals, exercise, hypo- and hyperglycaemia). Sensor performance was determined by fulfilment of ISO 15197:2013 criteria, calculating mean absolute relative difference (MARD), and was also illustrated using Parkes error grid and Bland-Altman plots. Sensor performance during changes in metabolic variables (lactate, betahydroxybutyrate, glucagon, non-esterified-fatty-acids) was determined by Spearman's rank correlation coefficient testing. The systems fulfilled ISO 15197:2013 criteria by 73.2% (Abbott), 56.1% (Dexcom) and 52.0% (Medtronic). The MARDs ± standard deviation in the entire glycaemic range were 13.2% ± 10.9% (Abbott), 16.8% ± 12.3% (Dexcom) and 21.4% ± 17.6% (Medtronic), respectively. All sensors performed less accurately during hypoglycaemia and best during hyperglycaemia. We did not observe an influence of metabolic variables on sensor performance.
authors.affiliation: Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
authors.forename: Felix
authors.identifier: 0000-0002-9947-1413
authors.initials: F
authors.lastname: Aberer
authors.affiliation: Joanneum Research GmbH, HEALTH - Institute for Biomedicine and Health Sciences, Graz, Austria.
authors.forename: Martin
authors.initials: M
authors.lastname: Hajnsek
authors.affiliation: Joanneum Research GmbH, HEALTH - Institute for Biomedicine and Health Sciences, Graz, Austria.
authors.forename: Markus
authors.initials: M
authors.lastname: Rumpler
authors.affiliation: Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
authors.forename: Sabine
authors.initials: S
authors.lastname: Zenz
authors.affiliation: Joanneum Research GmbH, HEALTH - Institute for Biomedicine and Health Sciences, Graz, Austria.
authors.forename: Petra M
authors.initials: PM
authors.lastname: Baumann
authors.affiliation: Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
authors.forename: Hesham
authors.initials: H
authors.lastname: Elsayed
authors.affiliation: Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
authors.forename: Adelheid
authors.initials: A
authors.lastname: Puffing
authors.affiliation: Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
authors.forename: Gerlies
authors.initials: G
authors.lastname: Treiber
authors.affiliation: Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.|Joanneum Research GmbH, HEALTH - Institute for Biomedicine and Health Sciences, Graz, Austria.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Pieber
authors.affiliation: Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
authors.forename: Harald
authors.initials: H
authors.lastname: Sourij
authors.affiliation: Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
authors.forename: Julia K
authors.initials: JK
authors.lastname: Mader
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D001317:Austria; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy / Q000378:metabolism*; D015444:Exercise; D005947:Glucose / Q000378:metabolism*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000175:diagnosis* / Q000378:metabolism; D007003:Hypoglycemia / Q000139:chemically induced / Q000175:diagnosis* / Q000378:metabolism; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007332:Insulin Infusion Systems / Q000009:adverse effects; D008422:Materials Testing; D062407:Meals; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000295:instrumentation* / Q000592:standards; D040521:Subcutaneous Tissue / Q000378:metabolism*; D055815:Young Adult
chemical_list: D005947:Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human
keywords: continuous glucose monitoring (CGM); glycaemic control; type 1 diabetes