Feasibility of a Glucose Manipulation Procedure for the Standardized Performance Evaluation of Continuous Glucose Monitoring Systems.

Abstract

Background: In continuous glucose monitoring (CGM) system performance studies, it is common to implement specific procedures for manipulating the participants' blood glucose (BG) levels during the collection of comparator BG measurements. Recently, such a procedure was proposed by a group of experts, and this study assessed its ability to produce combinations of BG levels and rates of change (RoCs) with certain characteristics.

Methods: During three separate in-clinic sessions conducted over 15 days, capillary BG measurements were carried out every 15 minutes for 7 hours. Simultaneously, the participants' BG levels were manipulated by controlling food intake and insulin administration to induce transient hyperglycemia and hypoglycemia. Subsequently, the combinations of BG levels and RoCs were categorized into dynamic glucose regions distinguishing between rapidly increasing BG levels (Alert high), hyperglycemia (BG high), rapidly falling BG levels (Alert low), and hypoglycemia (BG low).

Results: A total of 24 adult participants with type 1 diabetes were included. Capillary BG-RoC combinations showed 7.5% in the Alert high region, 13.3% in the BG high region, 9.8% in the Alert low region, and 11.0% in the BG low region. No adverse events related to the glucose manipulation procedure were documented.

Conclusions: As recommended by the experts, the percentage of data points in regions was ≥7.5%, demonstrating the procedure's feasibility. However, given that the recommendation for the alert high region was only barely achieved, we suggest optimizations to the procedure and definition of dynamic glucose regions to facilitate the procedures' adoption in standardized CGM performance evaluations.