Personal Considerations on Clinical Development of Continuous Glucose Monitoring Systems

To date, some glucose monitoring systems (GMS) are available, others arealready in the approval process, and more are in later stages of their clinicaldevelopment. Several clinical-experimental and clinical studies evaluating these GMS were performed and published in the last years giving diabetologists (and patients with diabetes) the opportunity to gain further insight into the performance of these GMS [1-3]. Clearly one of the aims of the interested diabetologist who is read-ing such publications is to learn about the advantages and disadvantages of the differ-ent GMS. He also would like to know if the performance of the different GMS is com-parable or not [4,5]. Such a comparison (at least to a given extent) is possible with dif-ferent blood glucose meters. However, the differences in the design of the published studies with GMS are so pronounced and the extent to which the details of the respec-tive studies are presented in the publications differ so much, that it is almost impossi-ble to compare the results obtained! In order to facilitate such an approach and guarantee a certain quality of the clinical development of GMS in the following some considerations are given and a standard-ized staged approach for the clinical development of GMS is proposed. GMS are not blood glucose meters