Performance of a Continuous Glucose Monitoring System During Controlled Hypoglycaemia in Healthy Volunteers

Abstract

It has been suggested that the continuous glucose monitoring system may be a useful tool for detecting unrecognised hypoglycaemia, especially at times when finger prick testing is difficult or impossible(e.g., at night). Studies suggest that subcutaneous glucose levels closely mimic blood glucose levels with a lag time of only a few minutes. However, no studies have been published to show how well the sensor performs during sustained or in recovery from hypoglycaemia. This study involved using a hyperinsulinaemic glucose clamp (60 mU/m²) in nine healthy volunteers. Each subject had two sensors inserted the day before the study. Blood glucose levels were maintained at euglycaemia for the first 60 min, then decreased to 45 mg/dL (2.5 mmol/L) for 60 min, and finally restored to euglycaemia. Blood glucose measurements were compared with interstitial values recorded by the sensor. Sensor profiles showed acceptable agreement with blood glucose levels at each of the three plateaus with a correlation coefficient of 0.79, slope of 0.85, and mean absolute error of 7%. The sensor drop closely matched the drop in blood glucose, but the recovery from hypoglycaemia was delayed by an average of 26 min. Continuous glucose sensing provides a useful means of detecting unrecognised hypoglycaemia in type 1 diabetes, although the duration of hypoglycaemia may be overestimated.