FreeStyle Libre and Dexcom G4 Platinum sensors: Accuracy comparisons during two weeks of home use and use during experimentally induced glucose excursions

Nutr Metab Cardiovasc Dis. 2018 Feb;28(2):180-186. doi: 10.1016/j.numecd.2017.10.023. Epub 2017 Nov 11.

Abstract

Background and aims: This study compared the accuracy of the FreeStyle Libre (Abbott, Alameda, CA) and Dexcom G4 Platinum (DG4P, Dexcom, San Diego, CA) CGM sensors.

Methods and results: Twenty-two adults with type 1 diabetes wore the two sensors simultaneously for 2 weeks. Libre was used according to manufacturer-specified lifetime (MSL); DG4P was used 7 days beyond MSL. At a clinical research center (CRC), subjects were randomized to receive the same breakfast with standard insulin bolus (standard) or a delayed and increased (delayed & increased) bolus to induce large glucose swings during weeks 1 and 2; venous glucose was checked every 5-15 min for 6 h. Subjects performed ≥4 reference fingersticks/day at home. Accuracy was assessed by differences in mean absolute relative difference (%MARD) in glucose levels compared with fingerstick test (home use) and YSI reference (CRC). During home-stay the Libre MARD was 13.7 ± 3.6% and the DG4P MARD 12.9 ± 2.5% (difference not significant [NS]). With both systems MARD increased during hypoglycaemia and decreased during hyperglycaemia, without significant difference between sensors. In the euglycaemic range MARD was smaller with DG4P [12.0 ± 2.4% vs 14.0 ± 3.6%, p = 0.026]. MARD increased in both sensors following delayed & increased vs. standard bolus (Libre: 14.9 ± 5.5% vs. 10.9 ± 4.1%, p = 0.008; DG4P: 18.1 ± 8.1% vs. 13.1 ± 4.6%, p = 0.026); between-sensor differences were not significant (p = 0.062). Libre was more accurate during moderate and rapid glucose changes.

Conclusions: DG4P and Libre performed similarly up to 7 days beyond DG4P MSL. Both sensors performed less well during hypoglycaemia but Libre was more accurate during glucose swings.

Trial registration: The study was registered in ClinicalTrials.gov (NCT02734745) April 12, 2016.

Keywords: Accuracy; Continuous glucose monitoring (CGM); Flash glucose monitoring; Hypoglycaemia; Rate of change; Type 1 diabetes.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Biomarkers / blood
  • Blood Glucose / drug effects
  • Blood Glucose / metabolism*
  • Blood Glucose Self-Monitoring / instrumentation*
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / diagnosis*
  • Diabetes Mellitus, Type 1 / drug therapy
  • Equipment Design
  • Female
  • Humans
  • Hypoglycemia / blood
  • Hypoglycemia / chemically induced
  • Hypoglycemia / diagnosis
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / adverse effects
  • Insulin / administration & dosage
  • Insulin / adverse effects
  • Italy
  • Male
  • Middle Aged
  • Predictive Value of Tests
  • Prospective Studies
  • Reproducibility of Results
  • Time Factors
  • Treatment Outcome
  • Young Adult

Substances

  • Biomarkers
  • Blood Glucose
  • Hypoglycemic Agents
  • Insulin

Associated data

  • ClinicalTrials.gov/NCT02734745