Self-monitoring of blood glucose two-weekly versus weekly in gestational diabetes on nutrition therapy: A randomized trial
Document Type
Article
Publication Date
11-1-2023
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 (). The first participant was recruited on April 12, 2022.
Keywords
blood sugar profile, cesarean delivery, diet, gestational diabetes, glycated hemoglobin, HbA1c, self-monitoring blood glucose
Divisions
obstetrics,ummc
Funders
Department of Obstetrics and Gynecology, Faculty of Medicine, Universiti Malaya (UMSCOG/RF00432022/02)
Publication Title
International Journal of Gynecology & Obstetrics
Volume
163
Issue
2
Publisher
Elsevier
Publisher Location
111 RIVER ST, HOBOKEN 07030-5774, NJ USA