Performance assessment of the Medtronic-MiniMed Continuous Glucose Monitoring System and its use for measurement of glycaemic control in Type 1 diabetic subjects

Diabet Med. 2003 Dec;20(12):1012-5. doi: 10.1046/j.1464-5491.2003.01037.x.

Abstract

Aims: To assess the accuracy, reliability and measurement of glycaemic control associated with the Medtronic-MiniMed Continuous Glucose Monitoring System (CGMS) in comparison with blood glucose self-monitoring (BGSM) in Type 1 diabetic patients.

Methods: Type 1 diabetic patients (n = 18) underwent glucose monitoring by the CGMS for up to 3 days, when control was also assessed by BGSM performed eight times daily.

Results: Ninety-five per cent of paired non calibration samples were in the clinically acceptable zones of the Clarke error grid, and 97% in a consensus grid. The median bias was 0.1 mmol/l and relative bias 15%. The failure rate of sensors was 28% of those initially inserted. The CGMS detected significantly more hypoglycaemia and post-prandial hyperglycaemia, but total duration of hyperglycaemia, blood glucose oscillations and day-to-day variability were similarly assessed by CGMS and BGSM.

Conclusions: The CGMS has acceptable clinical accuracy. Detection by the CGMS of more hypoglycaemia and post-prandial hyperglycaemia than BGSM promises a valuable tool for control assessment and optimization of treatment.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adult
  • Aged
  • Blood Glucose / analysis*
  • Blood Glucose Self-Monitoring / methods
  • Diabetes Mellitus, Type 1 / blood*
  • Eating / physiology
  • Female
  • Humans
  • Hyperglycemia / blood
  • Hypoglycemia / blood
  • Male
  • Middle Aged
  • Monitoring, Physiologic / instrumentation
  • Patient Satisfaction
  • Reproducibility of Results

Substances

  • Blood Glucose