Study . | Design . | Population . | Results . |
---|---|---|---|
Murphy et al., 2008 (46) | Multicenter, open-label RCT of blinded CGM reviewed every 4 weeks vs. standard care | 46 women with type 1 diabetes; 25 women with type 2 diabetes | Primary outcome: A1C at 32–36 weeks 5.8 vs. 6.4% (39.9 vs. 46.4 mmol/L) (P = 0.007)* |
Secondary outcomes: macrosomia: 35 vs. 60% (P = 0.05)*; no difference in mean gestational age at delivery, preeclampsia, rate of cesarean section, preterm delivery, NICU admission, or neonatal hypoglycemia | |||
Secher et al., 2013 (47) | Single-center RCT of rtCGM worn during weeks 8, 12, 21, 27, and 33 plus standard care vs. standard care | 123 women with type 1 diabetes; 31 women with type 2 diabetes | Primary outcome: LGA status 45 vs. 34% (P = 0.19) |
Secondary outcomes: no difference in A1C at 33 weeks, maternal hypoglycemia, preeclampsia, preterm delivery, or neonatal hypoglycemia | |||
Feig et al. (CONCEPTT), 2017 (1) | Multicenter, open-label RCT of rtCGM plus standard care vs. standard care | 215 women with type 1 diabetes | Primary outcome: A1C at 34 weeks mean difference −0.19%, 95% CI −0.34 to −0.03 (P = 0.0207)* |
Secondary outcomes: TAR 27 vs. 32% (P = 0.0279)*; TIR 68 vs. 61% (P = 0.0034)*; neonatal hypoglycemia OR 0.45, 95% CI 0.22–0.89 (P = 0.0250)*; NICU OR 0.48, 95% CI 0.26–0.86 (P = 0.0157)*; LGA status OR 0.51, 95% CI 0.28–0.90 (P = 0.0210)*; birth weight percentile 92 (95% CI 68–99) vs. 96 (95% CI 84–100) (P = 0.0489); no difference in TBR, maternal weight gain, gestational hypertension, preeclampsia, mode of delivery, maternal length of stay, preterm delivery, or macrosomia | |||
Voormolen et al. (GlucoMOMS), 2018 (45) | Multicenter, open-label RCT of blinded CGM reviewed every 6 weeks vs. standard care | 109 women with type 1 diabetes; 82 women with type 2 diabetes; 109 women with insulin-requiring GDM | Primary outcome: macrosomia 31.0 vs. 28.4% (RR 1.06, 95% CI 0.83–1.37) |
Secondary outcomes: preeclampsia 3.5 vs. 11.6% (RR 0.30, 95% CI 0.12–0.80)*; no difference in pregnancy-induced hypertension, HELLP syndrome, severe hypoglycemia, A1C, birth weight, LGA status, SGA status, preterm birth, neonatal mortality, birth trauma, or neonatal hypoglycemia | |||
Yu et al., 2014 (48) | Prospective cohort study of blinded CGM reviewed weekly for 4 weeks | 340 women with GDM | Primary outcomes: mean glucose 5.7 ± 0.5 vs. 5.7 ± 0.7 mmol/L (P = 0.253); glucose SD 0.8 ± 0.3 vs. 1.1 ± 0.4 mmol/L (P <0.001)*; mean amplitude of glycemic excursions 1.8 ± 0.6 vs. 2.4 ± 0.9 mmol/L (P <0.001)*; mean of daily differences 1.0 ± 0.2 vs. 1.2 ± 0.3 mmol/L (P <0.001)*; preeclampsia 3.4 vs. 10.1% (P = 0.019)*; primary cesarean delivery 34.7 vs. 46.6% (P = 0.028)*; composite neonatal outcome 27.4 vs. 49.5% (P <0.001)*† |
Secondary outcomes: duration of glycemia >7.8 mmol/L, 0 (95% CI 0–25) vs. 60 (95% CI 0–111) minutes/day (P <0.001)*; duration of glycemia <3.3 mmol/L, 0 (95% CI 0–0) vs. 0 (95% CI 0–25) minutes/day (P <0.001)*; premature delivery 4.8 vs. 11.8% (P = 0.024)*; birth weight percentile 66 vs. 82 (P <0.01)*; macrosomia 4.1 vs. 10.8% (P = 0.025)*; LGA status 13.7 vs. 25.8% (P <0.01)*; neonatal hypoglycemia 5.5 vs. 14% (P = 0.011)*; hyperbilirubinemia 2.7 vs. 9.7% (P = 0.012)*; no difference in SGA, NICU admissions, or neonatal respiratory distress syndrome† | |||
Wei et al., 2016 (49) | Open-label RCT of second- or third-trimester rtCGM vs. standard care | 106 women with GDM | Primary outcomes: cesarean section 60 vs. 69% (P = 0.370); Apgar score at 5 minutes 9.40 ± 0.56 vs. 9.49 ± 0.50 (P = 0.39); macrosomia 7.8 vs. 12.7% (P = 0.410); neonatal hypoglycemia 7.8 vs. 12.7% (P = 0.410); excess maternal weight gain 33.3 vs. 56.4% (P = 0.039)* |
Paramasivam et al., 2018 (50) | Open-label RCT of 3 weeks of blinded CGM vs. standard care | 50 women with insulin-requiring GDM | Primary outcome: A1C at 37 weeks 33 ± 4 mmol/mol (5.2 ± 0.4%) vs. 38 ± 7 mmol/mol (5.6 ± 0.6%) (P <0.006)*; no difference in maternal weight gain, gestational age and delivery, mode of delivery, neonatal hypoglycemia, NICU admission, median birth weight percentile, macrosomia, LGA status, or SGA status |
Study . | Design . | Population . | Results . |
---|---|---|---|
Murphy et al., 2008 (46) | Multicenter, open-label RCT of blinded CGM reviewed every 4 weeks vs. standard care | 46 women with type 1 diabetes; 25 women with type 2 diabetes | Primary outcome: A1C at 32–36 weeks 5.8 vs. 6.4% (39.9 vs. 46.4 mmol/L) (P = 0.007)* |
Secondary outcomes: macrosomia: 35 vs. 60% (P = 0.05)*; no difference in mean gestational age at delivery, preeclampsia, rate of cesarean section, preterm delivery, NICU admission, or neonatal hypoglycemia | |||
Secher et al., 2013 (47) | Single-center RCT of rtCGM worn during weeks 8, 12, 21, 27, and 33 plus standard care vs. standard care | 123 women with type 1 diabetes; 31 women with type 2 diabetes | Primary outcome: LGA status 45 vs. 34% (P = 0.19) |
Secondary outcomes: no difference in A1C at 33 weeks, maternal hypoglycemia, preeclampsia, preterm delivery, or neonatal hypoglycemia | |||
Feig et al. (CONCEPTT), 2017 (1) | Multicenter, open-label RCT of rtCGM plus standard care vs. standard care | 215 women with type 1 diabetes | Primary outcome: A1C at 34 weeks mean difference −0.19%, 95% CI −0.34 to −0.03 (P = 0.0207)* |
Secondary outcomes: TAR 27 vs. 32% (P = 0.0279)*; TIR 68 vs. 61% (P = 0.0034)*; neonatal hypoglycemia OR 0.45, 95% CI 0.22–0.89 (P = 0.0250)*; NICU OR 0.48, 95% CI 0.26–0.86 (P = 0.0157)*; LGA status OR 0.51, 95% CI 0.28–0.90 (P = 0.0210)*; birth weight percentile 92 (95% CI 68–99) vs. 96 (95% CI 84–100) (P = 0.0489); no difference in TBR, maternal weight gain, gestational hypertension, preeclampsia, mode of delivery, maternal length of stay, preterm delivery, or macrosomia | |||
Voormolen et al. (GlucoMOMS), 2018 (45) | Multicenter, open-label RCT of blinded CGM reviewed every 6 weeks vs. standard care | 109 women with type 1 diabetes; 82 women with type 2 diabetes; 109 women with insulin-requiring GDM | Primary outcome: macrosomia 31.0 vs. 28.4% (RR 1.06, 95% CI 0.83–1.37) |
Secondary outcomes: preeclampsia 3.5 vs. 11.6% (RR 0.30, 95% CI 0.12–0.80)*; no difference in pregnancy-induced hypertension, HELLP syndrome, severe hypoglycemia, A1C, birth weight, LGA status, SGA status, preterm birth, neonatal mortality, birth trauma, or neonatal hypoglycemia | |||
Yu et al., 2014 (48) | Prospective cohort study of blinded CGM reviewed weekly for 4 weeks | 340 women with GDM | Primary outcomes: mean glucose 5.7 ± 0.5 vs. 5.7 ± 0.7 mmol/L (P = 0.253); glucose SD 0.8 ± 0.3 vs. 1.1 ± 0.4 mmol/L (P <0.001)*; mean amplitude of glycemic excursions 1.8 ± 0.6 vs. 2.4 ± 0.9 mmol/L (P <0.001)*; mean of daily differences 1.0 ± 0.2 vs. 1.2 ± 0.3 mmol/L (P <0.001)*; preeclampsia 3.4 vs. 10.1% (P = 0.019)*; primary cesarean delivery 34.7 vs. 46.6% (P = 0.028)*; composite neonatal outcome 27.4 vs. 49.5% (P <0.001)*† |
Secondary outcomes: duration of glycemia >7.8 mmol/L, 0 (95% CI 0–25) vs. 60 (95% CI 0–111) minutes/day (P <0.001)*; duration of glycemia <3.3 mmol/L, 0 (95% CI 0–0) vs. 0 (95% CI 0–25) minutes/day (P <0.001)*; premature delivery 4.8 vs. 11.8% (P = 0.024)*; birth weight percentile 66 vs. 82 (P <0.01)*; macrosomia 4.1 vs. 10.8% (P = 0.025)*; LGA status 13.7 vs. 25.8% (P <0.01)*; neonatal hypoglycemia 5.5 vs. 14% (P = 0.011)*; hyperbilirubinemia 2.7 vs. 9.7% (P = 0.012)*; no difference in SGA, NICU admissions, or neonatal respiratory distress syndrome† | |||
Wei et al., 2016 (49) | Open-label RCT of second- or third-trimester rtCGM vs. standard care | 106 women with GDM | Primary outcomes: cesarean section 60 vs. 69% (P = 0.370); Apgar score at 5 minutes 9.40 ± 0.56 vs. 9.49 ± 0.50 (P = 0.39); macrosomia 7.8 vs. 12.7% (P = 0.410); neonatal hypoglycemia 7.8 vs. 12.7% (P = 0.410); excess maternal weight gain 33.3 vs. 56.4% (P = 0.039)* |
Paramasivam et al., 2018 (50) | Open-label RCT of 3 weeks of blinded CGM vs. standard care | 50 women with insulin-requiring GDM | Primary outcome: A1C at 37 weeks 33 ± 4 mmol/mol (5.2 ± 0.4%) vs. 38 ± 7 mmol/mol (5.6 ± 0.6%) (P <0.006)*; no difference in maternal weight gain, gestational age and delivery, mode of delivery, neonatal hypoglycemia, NICU admission, median birth weight percentile, macrosomia, LGA status, or SGA status |
All studies compared standard of care with SMBG to CGM plus standard care.
Statistically significant.
To convert the data shown here from mmol/L to mg/dL, multiply values by 18. HELLP, hemolysis, elevated liver enzymes, low platelet count.