Clinical Utility of SMBG: Recommendations on the Use and Reporting of SMBG in Clinical Research
Clinical Trials Friday, February 5th, 2016Diabetes Care, September 2015/p>
Quality glucose information is a core prerequisite for successful diabetes management. It enables professionals and people with diabetes to make medically relevant decisions on therapy. Details of glucose profile information beyond HbA1c have been largely derived from self-monitoring of blood glucose (SMBG). Given the evidence base demonstrating the benefits of SMBG, its routine use is recommended for diabetes management and therapy by many international and regional guidelines. Today, SMBG is considered an important aspect of the management of glycemic control. Glucose information of high quality, considering the products used and the processes conducted, is also needed in clinical research in order to gain new evidence and insights on effective treatment strategies in diabetes. SMBG is widely and routinely applied in large clinical trials, where it is used to understand the glycemic state, to enhance awareness of the effects of lifestyle modification and the adaptation of treatment including insulin titration, and to enable documentation of intraday pre- and postprandial glucose excursions (glycemic variability) and the subsequent statistical analysis of this and the confirmation of hypoglycemic episodes. …
Reliable glucose information requires a clear definition as part of the study design and protocol, not least to ensure replication of the methodology. Interpretation and comparison of study results may be affected if SMBG methods and results are addressed inconsistently. Read more.
