Continuous glucose monitoring in individuals undergoing gestational diabetes screening.

BACKGROUND: Among guidelines on gestational diabetes mellitus, there is an incongruity about the threshold of maternal hyperglycemia to diagnose gestational diabetes mellitus. OBJECTIVE: This study aimed to ascertain the association between continuous glucose monitoring metrics and adverse outcomes among individuals undergoing gestational diabetes mellitus screening. STUDY DESIGN: This was a prospective study (from June 2020 to January 2022) of individuals who underwent 2-step gestational diabetes mellitus screening at ≤30 weeks of gestation. The participants wore a blinded continuous glucose monitoring device (Dexcom G6 Pro; Dexcom, Inc, San Diego, CA) for 10 days starting when they took the 50-g glucose challenge test. The primary outcome was a composite of adverse neonatal outcomes (large for gestational age, shoulder dystocia or neonatal injury, respiratory distress, need for intravenous glucose treatment for hypoglycemia, or fetal or neonatal death). The secondary neonatal outcomes included preterm birth, neonatal intensive care unit admission, hypoglycemia, mechanical ventilation or continuous positive airway pressure, hyperbilirubinemia, and hospital length of stay. The secondary maternal outcomes included weight gain during pregnancy, hypertensive disorders of pregnancy, induction of labor, cesarean delivery, and postpartum complications. Time within the target range (63-140 mg/dL), time above the target range (>140 mg/dL) expressed as a percentage of all continuous glucose monitoring readings, and mean glucose level were analyzed. The Youden index was used to choose the threshold of ≥10% for the time above the target range and association with adverse outcomes. RESULTS: Of 136 participants recruited, data were available from 92 individuals (67.6%). The 2-step method diagnosed gestational diabetes mellitus in 2 individuals (2.2%). Continuous glucose monitoring indicated that 17 individuals (18.5%) had time above the target range of ≥10%. Individuals with time above the target range of ≥10% had a significantly higher likelihood of composite adverse neonatal outcomes than individuals with time above the target range of <10% (63% vs 18%; P=.001). Furthermore, compared with neonates born to individuals with time above the target range of <10%, neonates born to individuals with time above the target range of ≥10% had an increased likelihood for hypoglycemia (14.5% vs 47%; P=.009) and had a longer length of stay (2 vs 4 days; P=.03). No difference in maternal outcomes was noted between the groups. CONCLUSION: In this prospective study of individuals undergoing gestational diabetes mellitus screening, a cutoff of the time above the target range of ≥10% using continuous glucose monitoring was associated with a higher rate of neonatal adverse outcomes. A randomized trial of continuous glucose monitoring vs 2-step screening for gestational diabetes mellitus to lower the rate of adverse outcomes is underway (identification number: NCT05430204).

Time in Range and Pregnancy Outcomes in People with Diabetes Using Continuous Glucose Monitoring.

OBJECTIVE: The international consensus on continuous glucose monitoring (CGM) recommends time in range (TIR) target of >70% for pregnant people. Our aim was to compare outcomes between pregnant people with TIR ≤ versus >70%. STUDY DESIGN: This study was a retrospective study of all people using CGM during pregnancy from January 2017 to May 2021 at a tertiary care center. All people with pregestational diabetes who used CGM and delivered at our center were included in the analysis. Primary neonatal outcome included any of the following: large for gestational age, neonatal intensive care unit (NICU) admission, need for intravenous (IV) glucose, or respiratory distress syndrome (RDS). Maternal outcomes included hypertensive disorders of pregnancy and delivery outcomes. Logistic regression was used to estimate unadjusted and adjusted odds ratios (aORs) with 95% confidence intervals (CIs). RESULTS: Of 78 people managed with CGM, 65 (80%) met inclusion criteria. While 33 people (50.1%) had TIR ≤70%, 32 (49.2%) had TIR >70%. People with TIR ≤70% were more likely to be younger, have a lower body mass index, and have type 1 diabetes than those with TIR >70%. After multivariable regression, there was no difference in the composite neonatal outcome between the groups (aOR: 0.56, 95% CI: 0.16-1.92). However, neonates of people with TIR ≤70% were more likely to be admitted to the NICU (p = 0.035), to receive IV glucose (p = 0.005), to have RDS (p = 0.012), and had a longer hospital stay (p = 0.012) compared with people with TIR >70%. Furthermore, people with TIR ≤70% were more likely to develop hypertensive disorders (p = 0.04) than those with TIR >70%. CONCLUSION: In this cohort, the target of TIR >70% was reached in about one out of two people with diabetes using CGM, which correlated with a reduction in neonatal and maternal complications. KEY POINTS: · Among people with diabetes, 50% reached the recommended time in range using CGM.. · Time in range >70% was associated with reducing the rate of some neonatal complications.. · Time in range ≤70% was associated with increased risk for adverse maternal outcomes..

Maternal Education Level Among People with Diabetes and Associated Adverse Outcomes.

OBJECTIVE: The aim of the study is to determine the relation between education and adverse outcomes in individuals with pregestational or gestational diabetes. STUDY DESIGN: This population-based cohort study, using the U.S. vital statistics datasets, evaluated individuals with pregestational or gestational diabetes who delivered between 2016 and 2019. The primary outcome was composite neonatal adverse outcome including any of the following: large for gestational age (LGA), Apgar's score 6 hours, neonatal seizure, or neonatal death. The secondary outcome was composite maternal adverse outcomes including any of the following: admission to intensive care unit, transfusion, uterine rupture, or unplanned hysterectomy. Multivariable analysis was used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CIs). RESULTS: Of 15,390,962 live births in the United States, 858,934 (5.6%) were eligible for this analysis. Compared with individuals with a college education and above, the risk of composite neonatal adverse outcome was higher in individuals with some college (aRR = 1.08, 95% CI = 1.07-1.09), high school (aRR = 1.06, 95% CI = 1.04-1.07), and less than high school (aRR = 1.05, 95% CI = 1.03-1.07) education. The components of composite neonatal adverse outcome that differed significantly between the groups were LGA, Apgar's score 6 hours. Infant death differed when stratified by education level. An increased risk of composite maternal adverse outcome was also found with a lower level of education. CONCLUSION: Among individuals with diabetes, lower education was associated with a modestly higher risk of adverse neonatal and maternal outcomes. KEY POINTS: · Education levels were associated with adverse outcomes among individuals with diabetes.. · Lower education is associated with multiple neonatal complications, including infant death.. · Individuals with varying levels of education are at higher risk for adverse maternal outcomes..

Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial.

BACKGROUND: Insulin detemir, being used increasingly during pregnancy, may have pharmacologic benefits compared with neutral protamine Hagedorn. OBJECTIVE: We evaluated the probability that compared with treatment with neutral protamine Hagedorn, treatment with insulin detemir reduces the risk for adverse neonatal outcome among individuals with type 2 or overt type 2 diabetes mellitus (gestational diabetes mellitus diagnosed at <20 weeks' gestation). STUDY DESIGN: We performed a multiclinic randomized controlled trial (September 2018 to January 2020), which included women with singleton gestation with type 2 or overt type 2 diabetes mellitus who sought obstetrical care at ≤21 weeks' gestation. Participants were randomized to receive either insulin detemir or neutral protamine Hagedorn by a clinic-stratified scheme. The primary outcome was a composite of adverse neonatal outcomes, including shoulder dystocia, large for gestational age, neonatal intensive care unit admission, respiratory distress (defined as the need of at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure or ventilation at the first 24 hours of life), or hypoglycemia. The secondary neonatal outcomes included gestational age at delivery, small for gestational age, 5-minute Apgar score of <7, lowest glucose level, need for intravenous glucose, respiratory distress syndrome, need for mechanical ventilation or continuous positive airway pressure, neonatal jaundice requiring therapy, brachial plexus injury, and hospital length of stay. The secondary maternal outcomes included hypoglycemic events, hospital admission for glucose control, hypertensive disorder of pregnancy, maternal weight gain, cesarean delivery, and postpartum complications. We used the Bayesian statistics to estimate a sample size of 108 to have >75% probability of any reduction in the primary outcome, assuming 80% power and a hypothesized effect of 33% reduction with insulin detemir. All analyses were intent to treat under a Bayesian framework with neutral priors (a priori assumed a 50:50 likelihood of either intervention being better; National Clinical Trial identifier 03620890). RESULTS: There were 108 women randomized in this trial (57 in insulin detemir and 51 in neutral protamine Hagedorn), and 103 women were available for analysis of the primary outcome (n=5 for pregnancy loss before 24 weeks' gestation). Bayesian analysis indicated an 87% posterior probability of reduced primary outcome with insulin detemir compared with neutral protamine Hagedorn (posterior adjusted relative risk, 0.88; 95% credible interval, 0.61-1.12). Bayesian analyses for secondary outcomes showed consistent findings of lower adverse maternal outcomes with the use of insulin detemir vs neutral protamine Hagedorn: for example, maternal hypoglycemic events (97% probability of benefit; posterior adjusted relative risk, 0.59; 95% credible interval, 0.29-1.08) and hypertensive disorders (88% probability of benefit; posterior adjusted relative risk, 0.81; 95% credible interval, 0.54-1.16). CONCLUSION: In our comparative effectiveness trial involving individuals with type 2 or overt type 2 diabetes mellitus, use of insulin detemir resulted in lower rates of adverse neonatal and maternal outcomes compared with neutral protamine Hagedorn.