Our team has recently published the first comprehensive overview of the use of blood glucose monitoring in phase III clinical studies of insulin analogs, “Systematic literature review of use of blood glucose monitoring in phase III clinical studies of insulin analogs”, in one of the leading European journals in endocrine disorders – BMC Endocrine Disorders.
The objective of the study was to explore the use of blood glucose measurement in phase-III clinical studies of insulin analogs. These studies provide safety and efficacy information for regulatory authorities and are the basis for insulin analog regulatory approval. Altogether 46 phase III clinical trials were identified in the manufacturers’ websites. Of the identified phase III studies, 62 % (n = 28) were rapid-acting insulin analog studies and 38 % (n = 17) were pre-mixed insulin analog studies. Of the rapid-acting analogs, 29 % (n = 8) were insulin aspart, 57 % (n = 16) were insulin glulisine and 14 % (n = 4) were insulin lispro. Of the pre-mixed insulin analog studies, 71 % (n = 12) were biphasic insulin aspart studies and 29 % (n = 5) insulin lispro mix studies. To our knowledge, the present study is the first to systematically assess the role of self-monitoring of blood glucose (SMBG) in phase III clinical studies. It confirms the role of blood glucouse measurement as an essential component of safe and effective insulin therapy. We found that in 100 % of phase-III clinical studies of analog insulins, blood glucose monitoring was regularly used. SMBG was the most prevalent monitoring option and was reported in 93 % of the studies. To conclude, the findings from this review endorse the crucial role of blood glucose measurement in general and of SMBG specifically as a co-dependent intervention component of insulin treatment. The majority of phase III registration studies reported on the use of blood glucose measurements for establishing safe and efficacious administration of insulin. The indispensable role of SMBG in treatment for insulin-dependent patients should receive the attention of health care payers in order to consistently assess and reimburse SMBG along with insulins to ensure the safety and effectiveness of insulin treatment.