Performance assessment of the Medtronic-MiniMed Continuous Glucose Monitoring System and its use for measurement of glycaemic control in Type 1 diabetic subjects.
OBJECTIVE
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.
Sachedina
N
N
Metabolic Unit, Guy's, King's and St Thomas's School of Medicine, Guy's Hospital, London, UK.
Pickup
J C
JC
D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000379:methods; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D004435:Eating / Q000502:physiology; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000097:blood; D007003:Hypoglycemia / Q000097:blood; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000295:instrumentation; D017060:Patient Satisfaction; D015203:Reproducibility of Results
D001786:Blood Glucose