Evaluation of subcutaneous glucose monitoring systems under routine environmental conditions in patients with type 1 diabetes

Diabetes Obes Metab. 2017 Jul;19(7):1051-1055. doi: 10.1111/dom.12907. Epub 2017 Mar 16.

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.

Keywords: continuous glucose monitoring (CGM); glycaemic control; type 1 diabetes.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Activities of Daily Living*
  • Adult
  • Austria
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / drug therapy
  • Diabetes Mellitus, Type 1 / metabolism*
  • Exercise
  • Glucose / metabolism*
  • Glycated Hemoglobin / analysis
  • Humans
  • Hyperglycemia / diagnosis*
  • Hyperglycemia / metabolism
  • Hypoglycemia / chemically induced
  • Hypoglycemia / diagnosis*
  • Hypoglycemia / metabolism
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use
  • Injections, Subcutaneous
  • Insulin / administration & dosage
  • Insulin / adverse effects
  • Insulin / therapeutic use
  • Insulin Infusion Systems / adverse effects
  • Materials Testing
  • Meals
  • Middle Aged
  • Monitoring, Ambulatory / instrumentation*
  • Monitoring, Ambulatory / standards
  • Subcutaneous Tissue / metabolism*
  • Young Adult

Substances

  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin
  • hemoglobin A1c protein, human
  • Glucose