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

Abstract

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 HbA 1c 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 (1-3). Today, SMBG is considered an important aspect of the management of glycemic control (3,4). 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. Examples of recent studies that used SMBG are Outcome Reduction With Initial Glargine Intervention (ORIGIN) trial, Action to Control Cardiovascular Risk in Diabetes (ACCORD), and, from earlier times, the Diabetes Control and Complications Trial (DCCT) (5-8). Indeed, SMBG is now applied in most studies of glucoselowering agents, including glucagon-like peptide 1 (GLP-1) receptor agonist and sodium-glucose cotransporter 2 (SGLT2) inhibitor studies.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. With regard to the interpretation of outcomes of studies, reporting of SMBG in publications should be of the highest qualitydaccurate, precise, reliable, and reproducible. In many publications, however, relevant details of the SMBG measures are lacking or are incomplete. Therefore, the interpretation of study results may be hampered, reliability of study results may be compromised, and repetition of trials may become necessary.This consensus publication not only aims to summarize learnings from previous clinical studies about the use and reporting of SMBG but also proposes recommendations for the description of the performance and reporting of SMBG in future clinical study protocols and related publications.Clinical trials aim at expanding knowledge and evidence. One major principle of Good Clinical Practice is to conduct clinical studies at a quality standard that provides the highest level of safety for the study participants but also avoids a potentially unnecessary burden on participants by inefficient repetition of the experiments with "human beings" to answer a clinical/scientific qu...

Assessment of compliance to self monitoring of blood glucose in type 2 diabetic patients and level of implementation of Polish Diabetes Association Recommendation for general practitioners

“…The benefits of correct self-monitoring of glycaemia have been widely discussed in the last decade [5][6][7]. It was proven that patients with asymptomatic hypoglycaemia and those treated with insulin -especially with the intensive insulin therapy regimen --can benefit from self-monitoring performed with a glucometer [7,8].…”

“…It was proven that patients with asymptomatic hypoglycaemia and those treated with insulin -especially with the intensive insulin therapy regimen --can benefit from self-monitoring performed with a glucometer [7,8]. There is some controversy regarding self-monitoring of blood glucose in type 2 diabetes patients treated with oral hypoglycaemic medications.…”

“…Perhaps it is a result of either lack of patients' capability to modify the treatment themselves, or no adequate intervention of the physician assessing the data. A number of clinical studies concerning self monitoring of glycaemia have raised the question of data loss, incomplete data or no compliance [7].…”

Evaluation of a Behavioral Mobile Phone App Intervention for the Self-Management of Type 2 Diabetes: Randomized Controlled Trial Protocol

“…However, for T2DM patients that are not treated with insulin, the standard approach of simply recommending SMBG without the appropriate guidelines and training will not facilitate behavior change [4]. Polonsky outlines four main considerations for SMBG amongst this specific population: (1) SMBG should be structured and performed regularly around key events (eg, meals), (2) patients need to be provided with SMBG-related training, (3) clinicians must be able to view SMBG data and use it to inform clinical decisions, and (4) useful display of SMBG data to facilitate pattern identification [3].…”

“…Self-monitoring of blood glucose (SMBG) continues to be prescribed to patients as a self-management tool without the additional context, education, and frequent feedback required to interpret trends and adjust behaviors accordingly [3,4]. …”