Endocrine Abstracts

Background and aims: The ISO guideline 15197 lays out the system accuracy (SA) and user performance (UP) evaluation requirements for BGMS for self-testing in managing diabetes mellitus. They require the measurement of blood glucose to be tested across a spectrum of glucose ranges to demonstrate accuracy, including within the hypoglycemic range. Fulfilling the requirements for accuracy evaluations at the hypoglycaemic range can be challenging. The aim of the study was to show that a modified hypoglycaemic glucose clamp can be used to fast-track the evaluation of new BGMS in hypoglycaemic ranges for regulatory purposes.

Materials and methods: Nineteen patients with type 1 Diabetes participated in a hypoglycemic clamp to evaluate the SA and UP of a BGMS within the hypoglycemic range (63–75 mg/dl). Demographic data of study population was: age 30±1.7 years; duration of diabetes 13.1±1.7 years; mean HbA1c 64.63±3.96 mmol/mol). Patients had no pre-existing significant microvascular or macrovascular complications of diabetes and had been performing self-monitoring since diagnosis. During the hypoglycemic glucose clamp blood glucose levels were maintained in a stable non dynamic state during which the BGMSs were investigated for UP/SA and confirmed by an industry standard reference instrument (YSI 2300).

Results: About 19/19 patients successfully completed the hypoglycemic glucose clamp. 18 patients met the UP ISO requirements (±15 mg/dl of the average values of the reference measurement procedure at glucose concentrations 100 mg/dl) one subject did not meet these requirements (16.2 mg/dl) due to patient sample application error. 15 of the 15 subjects evaluated for SA met the ISO requirements (±15 mg/dl of the results of the reference measurement procedure at glucose concentrations 75 mg/dl).

Conclusion: These results demonstrate that the modified hyperinsulinemic hypoglycemic glucose clamp is a safe, robust and reliable method of evaluating the accuracy of BGMSs at levels of hypoglycemia for regulatory purposes.