Center for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark.
Diabetes Care. 2013 Jul;36(7):1877-83. doi: 10.2337/dc12-2360. Epub 2013 Jan 24.
To assess whether intermittent real-time continuous glucose monitoring (CGM) improves glycemic control and pregnancy outcome in unselected women with pregestational diabetes.
A total of 123 women with type 1 diabetes and 31 women with type 2 diabetes were randomized to use real-time CGM for 6 days at 8, 12, 21, 27, and 33 weeks in addition to routine care, including self-monitored plasma glucose seven times daily, or routine care only. To optimize glycemic control, real-time CGM readings were evaluated by a diabetes caregiver. HbA1c, self-monitored plasma glucose, severe hypoglycemia, and pregnancy outcomes were recorded, with large-for-gestational-age infants as the primary outcome.
Women assigned to real-time CGM (n = 79) had baseline HbA1c similar to that of women in the control arm (n = 75) (median 6.6 [range 5.3-10.0] vs. 6.8% [5.3-10.7]; P = 0.67) (49 [34-86] vs. 51 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]; P = 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]; P = 0.64) were comparable regardless of real-time CGM use, and a similar fraction of women had experienced severe hypoglycemia (16 vs. 16%; P = 0.91). The prevalence of large-for-gestational-age infants (45 vs. 34%; P = 0.19) and other perinatal outcomes were comparable between the arms.
In this randomized trial, intermittent use of real-time CGM in pregnancy, in addition to self-monitored plasma glucose seven times daily, did not improve glycemic control or pregnancy outcome in women with pregestational diabetes.
评估在未经选择的孕前糖尿病女性中，间歇性实时连续血糖监测（CGM）是否改善血糖控制和妊娠结局。
共有 123 例 1 型糖尿病女性和 31 例 2 型糖尿病女性被随机分为两组，在常规护理（包括每日自我监测 7 次血糖）的基础上，分别额外使用实时 CGM 监测 6 天（在妊娠 8、12、21、27 和 33 周时进行监测）或仅接受常规护理。为了优化血糖控制，由糖尿病护理人员对实时 CGM 读数进行评估。记录糖化血红蛋白（HbA1c）、自我监测的血浆葡萄糖、严重低血糖和妊娠结局，巨大儿是主要结局。
实时 CGM 组（n=79）的女性基线 HbA1c 与对照组（n=75）相似（中位数 6.6[范围 5.3-10.0] vs. 6.8%[5.3-10.7]；P=0.67）（49[34-86] vs. 51mmol/mol[34-93]）。49（64%）名女性按方案使用实时 CGM。在 33 周时，HbA1c（6.1[5.1-7.8] vs. 6.1%[4.8-8.2]；P=0.39）（43[32-62] vs. 43mmol/mol[29-66]）和自我监测的血浆葡萄糖（6.2[4.7-7.9] vs. 6.2mmol/L[4.9-7.9]；P=0.64）在是否使用实时 CGM 方面没有差异，且严重低血糖的发生比例相似（16 对 16%；P=0.91）。巨大儿的发生率（45 对 34%；P=0.19）和其他围产期结局在两组之间相似。
在这项随机试验中，在常规每日自我监测 7 次血糖的基础上，妊娠期间间歇性使用实时 CGM 并未改善孕前糖尿病女性的血糖控制或妊娠结局。
