OBJECTIVE To assess whether intermittent real-time continuous glucose monitoring (CGM) improves glycemic control and pregnancy outcome in unselected women with pregestational diabetes. mmol/mol [34-93]). Forty-nine (64%) women used real-time CGM per protocol. At 33 weeks HbA1c (6.1 [5.1-7.8] vs. 6.1% [4.8-8.2]; = 0.39) (43 [32-62] vs. 43 mmol/mol [29-66]) and self-monitored plasma glucose (6.2 [4.7-7.9] vs. 6.2 mmol/L [4.9-7.9]; = 0.64) were comparable regardless of real-time CGM use and a similar fraction of women had experienced severe hypoglycemia (16 vs. 16%; = 0.91). The prevalence of large-for-gestational-age infants (45 vs. 34%; = 0.19) and other perinatal outcomes were comparable between the arms. CONCLUSIONS In Rabbit Polyclonal to CFLAR. this randomized trial intermittent use of real-time CGM in pregnancy in addition to self-monitored plasma glucose seven occasions daily did not improve glycemic control or SB SB 252218 252218 pregnancy outcome in women with pregestational diabetes. SB 252218 Pregnancy in women with pregestational diabetes is still associated with adverse perinatal outcomes largely attributed to maternal hyperglycemia including large-for-gestational-age infants preterm delivery and perinatal morbidity (1-4). Large-for-gestational-age infants to mothers with diabetes are at increased risk for birth trauma transient tachypnea and neonatal hypoglycemia (5) and maternal diabetes in pregnancy is associated with later-life morbidity in the offspring (6). The major barrier in the strive for rigid maternal glycemic control is the risk of severe hypoglycemia (1) occurring up to five occasions more frequently in early pregnancy than in the period prior to pregnancy in women with type 1 diabetes (7). Real-time continuous glucose monitoring (CGM) measures interstitial glucose in an ongoing fashion and offers the possibility of hyper- and hypoglycemic alarms. Studies of nonpregnant patients with type 1 diabetes indicate that real-time CGM lowers HbA1c (8-19) and may reduce the tendency to biochemical hypoglycemia (9). Pregnant women with diabetes may also profit from real-time CGM but experience is still limited SB 252218 (20-26). A randomized controlled trial evaluating intermittent use of a previous CGM system (not real-time) on top of routine pregnancy care reported improved glycemic control and a reduced risk of large-for-gestational-age infants in the intervention arm (27). Against this background it is tempting to SB 252218 suggest that women with pregestational diabetes would benefit even more from the use of real-time CGM in pregnancy. In this investigator-driven trial we therefore aimed to assess whether intermittent real-time CGM as part of routine pregnancy care could improve maternal glycemic control and pregnancy outcome in an unselected cohort of women with pregestational type 1 or type 2 diabetes. RESEARCH DESIGN AND METHODS Patients During the study period of 15 February 2009 to 15 February 2011 all Danish-speaking pregnant women with pregestational diabetes referred to the Center for Pregnant Women with Diabetes Rigshospitalet before 14 completed gestational weeks with one living intrauterine fetus (= 222) were offered participation in the study (Fig. 1). Patients were referred from the Capital Region SB 252218 of Denmark and Region Zealand covering 2.4 million inhabitants. Exclusion criteria were present use of real-time CGM (= 7) severe mental or psychiatric barriers (= 4) diabetic nephropathy (= 3) or severe concurrent comorbidity (one with severe psoriasis and two with previous gastric bypass surgery). If a woman had more than one pregnancy in the study period (= 4) the woman was only offered inclusion at first referral. Among eligible patients a total of 123 (79%) women with type 1 diabetes and 31 (67%) women with type 2 diabetes were accepted to take part in the study of whom 79 (51%) women were randomized to intermittent use of real-time CGM in pregnancy in addition to routine pregnancy care (see below). The major reason for rejecting participation was the possibility of real-time CGM allocation. Physique 1 Progression of women through the trial. (A high-quality color representation of this figure is available in the online issue.) The research protocol was.