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CGM improves neonatal outcomes in type 1 diabetes
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Pregnant women with type 1 diabetes using continuous glucose monitoring had a lower risk for adverse neonatal outcomes and experienced reductions in HbA1c compared with those not using the technology, according to findings from the CONCEPTT trial presented at the European Association for the Study of Diabetes Annual Meeting and published simultaneously in The Lancet.
“All women should be offered CGM to reduce neonatal complications,” Denice S. Feig, MD, MSc, FRCP, associate professor at the University of Toronto and head of the Diabetes and Endocrinology in Pregnancy program at Mt. Sinai Hospital, told Endocrine Today. “Randomized controlled trials of closed-loop [insulin delivery] during pregnancy to try to improve time in target and neonatal outcomes even more are needed.”
Feig and colleagues evaluated data from the CONCEPTT trial on 325 women with type 1 diabetes who were pregnant or planning pregnancy randomly assigned to capillary glucose monitoring with CGM or without CGM (controls) to determine the effectiveness of CGM on maternal glucose control and obstetric and neonatal outcomes.
The primary outcome was change in HbA1c from randomization to 34 weeks’ gestation in pregnant women and 24 weeks’ gestation or conception in women planning pregnancy; secondary outcomes included obstetric and neonatal health outcomes.
Participants were divided into two separate trials to determine the outcomes: the pregnancy trial (n = 108 assigned to CGM) and the planning pregnancy trial (n = 57 assigned to CGM).
From baseline to 34 weeks’ gestation, researchers observed a small but significant between-group difference in change in HbA1c favoring the CGM group compared with controls in the pregnancy trial (P = .0207). A difference in HbA1c was observed in the planning pregnancy trial, but it was not significant.
In the pregnancy trial, time spent in the recommended glucose control target range (3.5-7.8 mmol/L) was longer and time spent above target shorter in the CGM group compared with controls at 34 weeks’ gestation. No between-group differences were observed in the planning pregnancy trial for glycemic outcomes except an increase in the rate of change in glucose concentrations.
No between-group differences were observed for hypertensive disorders, preeclampsia, cesarean delivery, gestational age or preterm delivery in either the pregnancy or planning pregnancy trials.
Pregnant participants assigned to CGM had a decreased risk for an infant large for gestational age (OR = 0.51; 95% CI, 0.28-0.9), and their infants had reduced total length of hospital stay (P = .0091) and were less likely to require neonatal ICU admissions lasting more than 24 hours (OR = 0.48; 95% CI, 0.26-0.86) or to experience hypoglycemia requiring treatment with IV dextrose (OR = 0.45; 95% CI, 0.22-0.89) compared with controls and infants of controls.
Among all participants, those assigned to CGM were more likely to experience adverse events — the most common were skin reactions — compared with controls. Serious adverse events were uncommon among all participants, but the most common were gastrointestinal.
“Keeping blood sugar levels within the normal range during pregnancy for women with type 1 diabetes is crucial to reduce risks for the mother and child,” Feig said in a press release. “However, with traditional monitoring this can be difficult as sensitivity to insulin fluctuates through pregnancy, meaning that accurately adjusting insulin doses is complex. As a result of our findings, we believe that this type of monitoring should be offered to all pregnant women with type 1 diabetes.” – by Amber Cox
In the accompanying editorial, Satish K. Garg, MD, and Sarit Polsky, MD, both of the Barbara Davis Center for Diabetes at the University of Colorado Denver, wrote that “previous studies have shown little or no effect on maternal and fetal outcomes.”
“The fact that CONCEPTT showed significant effects on the proportion of infants large for gestational age and on neonatal intensive care unit duration of stay with frequent CGM use is akin to studies in nonpregnant populations showing favorable outcomes with comparable CGM use,” they wrote. “We believe that the CONCEPTT results support CGM use during pregnancy for all women with type 1 diabetes, and time in range might become an important measure in pregnancies associated with type 1 diabetes; thus, endocrine and obstetric medical societies could consider advocating or recommending revising their guidelines accordingly.” – by Amber Cox
For more information:
Denice S. Feig, MD, MSc, FRCP, can be reached at d.feig@utoronto.ca.
References:
Feig DS, et al. Continuous glucose monitoring before and during pregnancy in women with type 1 diabetes: Results from CONCEPTT; a multicenter multinational randomized controlled trial. Presented at: European Association for the Study of Diabetes Annual Meeting; Sept. 11-15, 2017; Lisbon, Portugal.
Feig DS, et al. Lancet. 2017;doi:10.1016/S0140-6736(17)32400-5.
Garg SK, Polsky S. Lancet. 2017;doi:10.1016/S0140-6736(17)32449-2.
Disclosures: Feig reports she receives grants from JDRF. Garg reports he receives advisory board consulting fees from Eli Lilly, Johnson & Johnson, Lexicon, Mannkind, Medtronic, Merck, Novo Nordisk, Roche, Sanofi and TID exchange, and grants from Dario, DexCom, Eli Lilly, Lexicon, Mannkind, Medtronic, Merck, Novo Nordisk, Sanofi and T1D Exchange. Polsky reports she receives research funding from DexCom.