TY - JOUR
T1 - Clinical utility of SMBG
T2 - Recommendations on the use and reporting of SMBG in clinical research
AU - Schnell, Oliver
AU - Barnard, Katharine
AU - Bergenstal, Richard
AU - Bosi, Emanuele
AU - Garg, Satish
AU - Guerci, Bruno
AU - Haak, Thomas
AU - Hirsch, Irl B.
AU - Ji, Linong
AU - Joshi, Sashank R.
AU - Kamp, Maarten
AU - Laffel, Lori
AU - Mathieu, Chantal
AU - Polonsky, William H.
AU - Snoek, Frank
AU - Home, Philip
PY - 2015/9/1
Y1 - 2015/9/1
N2 - 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.
AB - 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.
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U2 - 10.2337/dc14-2919
DO - 10.2337/dc14-2919
M3 - Article
C2 - 26294772
AN - SCOPUS:84962406452
VL - 38
SP - 1627
EP - 1633
JO - Diabetes Care
JF - Diabetes Care
SN - 1935-5548
IS - 9
ER -