Self‐monitoring of blood glucose two‐weekly versus weekly in gestational diabetes on nutrition therapy: A randomized trial

Abstract

ObjectiveTo evaluate 4‐point per day self‐monitoring of blood glucose (SMBG) every 2 weeks compared with every week.MethodsA total of 104 patients with lifestyle‐controlled gestational diabetes (GDMA1) were randomized to 2‐weekly or weekly 4‐point per day (fasting on awakening and 2‐h post‐meals) SMBG. Primary outcome was the change in glycated hemoglobin (HbA1c) level from enrollment to 36 weeks of pregnancy across trial arms. The non‐inferiority margin was an HbA1c increase of 0.2%.ResultsThe mean difference for change in HbA1c from enrollment to 36 weeks was 0.003% (95% confidence interval [CI] –0.098% to +0.093%), within the 0.2% non‐inferiority margin. The change in HbA1c level increased significantly within both trial arms—0.275% ± 0.241% (P < 0.001) in 2‐weekly arm versus 0.277% ± 0.236% (P < 0.001) in the weekly arm. Participants randomized to 2‐weekly SMBG were significantly less likely to receive anti‐glycemic treatment—5/52 (9.6%) versus 14/50 (28.0%) (relative risk 0.34, 95% CI 0.13–0.88; P = 0.017). All secondary outcomes—maternal weight gain, preterm delivery, cesarean delivery, birthweight, and neonatal admission—were not significantly different.ConclusionsIn GDMA1, 2‐weekly is non‐inferior to weekly SMBG on the change in HbA1c level. Two‐weekly SMBG appeared to be adequate for monitoring women with GDMA1.Clinical Trial RegistrationThis study was registered in ISRCTN registry on March 25, 2022 with trial identification number: ISRCTN13404790 (https://doi.org/10.1186/ISRCTN13404790). The first participant was recruited on April 12, 2022.