Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Mount Sinai West, Icahn School of Medicine at Mount Sinai, New York, New York.
Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.
Am J Perinatol. 2023 Aug;40(11):1149-1157. doi: 10.1055/a-2053-7650. Epub 2023 Mar 14.
Gestational diabetes mellitus (GDM) requires close surveillance of blood glucose to prevent perinatal morbidity. Self-monitoring of capillary blood glucose (BGM) comes with considerable psychosocial burden. Intermittently scanned continuous glucose monitor (isCGM) devices are discreet and could considerably impact the lifestyle of the patient. They are designed to replace BGM testing in nonpregnant patients. Data on this technology in pregnancy are scant. The aim of this study was to assess concordance of BGM with isCGM in GDM.
Institutional review board approved prospective single-arm study evaluating agreement of isCGM (Freestyle Libre 14-day system) compared with BGM when determining glucose levels fasting and 2-hour postprandial for 14 days. This was documented as percentage of results within Zone A (clinically accurate measurements with no effect on clinical action) or Zone B (values that deviate from reference by >20% but would lead to benign/no treatment) of the Parkes Error Grid (developed for nonpregnant patients with diabetes). Per International Organization for Standardization criteria, agreement was defined as >95% within Zone A or B. Analytical agreement was evaluated using mean and median absolute relative difference (ARD), mean and median absolute difference (AD).
There were 1,604 pairs of BGM/isCGM observations for 41 patients. Mean glucose values were 102.0 (standard deviation [SD] = 20.5) and 89.4 (SD = 20.1) mg/dL for BGM and isCGM, respectively. Mean and median AD were 15.9 and 13.0 mg/dL, respectively. Mean and median ARD were 15.9 and 12.5%, respectively. Zones A and B contained 76.9 and 22.9% of values, respectively, in the Parkes Error Grid, for a total of 99.8%.
BGM and isCGM demonstrate clinical agreement. However, glucose values with isCGM trended lower, with greater mean and median ARD than prior studies. Given the strict glycemic control required during pregnancy, physicians should be aware of these differences and their possible clinical implications.
· Gestational diabetes mellitus requires close surveillance of blood glucose.. · isCGM is painless and discreet; however, values trend lower than capilary blood glucose.. · Physicians should be aware of these differences and possible clinical implications..
妊娠糖尿病（GDM）需要密切监测血糖，以预防围产期发病率。毛细血管血糖自我监测（BGM）会带来相当大的心理社会负担。间歇性扫描连续血糖监测仪（isCGM）设备隐蔽，可极大地影响患者的生活方式。它们旨在替代非妊娠患者的 BGM 检测。有关该技术在妊娠中的数据很少。本研究的目的是评估 GDM 中 BGM 与 isCGM 的一致性。
机构审查委员会批准了一项前瞻性单臂研究，评估了 14 天内 isCGM（Freestyle Libre 14 天系统）与 BGM 相比，在空腹和餐后 2 小时确定血糖水平时的一致性。这是通过将结果记录为 Parkes 误差网格的 A 区（临床准确测量，对临床决策无影响）或 B 区（与参考值相差>20%但不会导致良性/无需治疗）的百分比来记录的（为非妊娠糖尿病患者开发）。根据国际标准化组织的标准，一致性定义为 A 区或 B 区>95%。使用平均和中位数绝对相对差异（ARD）、平均和中位数绝对差异（AD）评估分析一致性。
共有 41 名患者的 1604 对 BGM/isCGM 观察值。BGM 和 isCGM 的平均血糖值分别为 102.0（标准差[SD] = 20.5）和 89.4（SD = 20.1）mg/dL。平均和中位数 AD 分别为 15.9 和 13.0 mg/dL。平均和中位数 ARD 分别为 15.9 和 12.5%。Parkes 误差网格中 A 区和 B 区分别包含 76.9%和 22.9%的数值，总共有 99.8%。
BGM 和 isCGM 具有临床一致性。然而，与之前的研究相比，isCGM 的血糖值趋势更低，平均和中位数 ARD 更高。鉴于妊娠期间需要严格的血糖控制，医生应了解这些差异及其可能的临床意义。
· 妊娠糖尿病需要密切监测血糖。
· isCGM 无痛且隐蔽；然而，与毛细血管血糖相比，其值趋势更低。
· 医生应了解这些差异及其可能的临床意义。
