Clinical Utility of SMBG: Recommendations on the Use and Reporting of SMBG in Clinical Research

SMBG is widely used in clinical trials. Researchers recognize the importance of documenting glycemic variability, postprandial glucose excursions, and symptomatic and asymptomatic hypoglycemic episodes in their study participants. Furthermore, SMBG data are often used in clinical trials to guide the prescription and dosage of diabetes medications according to specific algorithms. Looking ahead, data-management technology, which appears to facilitate daily diabetes management (44), may gain increasing relevance in studies. In the scientific literature, however, information on the implementation of SMBG in clinical trials and reporting of SMBG data are often lacking or incomplete. We, therefore, recommend a more standardized approach for SMBG in trial protocols as well as in publications where applicable. That may improve the comparability and scientific force of clinical studies. Research should aim at being highly efficient, being meaningful to the community, and avoiding the need for renewed examination. Therefore, an accurate description of how SMBG should be performed and applied in study protocols is required. Subsequently, all relevant findings and aspects related to SMBG should be reported. As a result, we expect that the comparability and scientific force of clinical studies will be enhanced and that it will become much easier to compare SMBG data across studies.