Division of Research, Kaiser Permanente, Oakland, California.
Kaiser Northern California Diabetes Program, Endocrinology and Internal Medicine, Kaiser Permanente, South San Francisco Medical Center, South San Francisco, California.
JAMA. 2021 Jun 8;325(22):2273-2284. doi: 10.1001/jama.2021.6530.
Continuous glucose monitoring (CGM) is recommended for patients with type 1 diabetes; observational evidence for CGM in patients with insulin-treated type 2 diabetes is lacking.
To estimate clinical outcomes of real-time CGM initiation.
DESIGN, SETTING, AND PARTICIPANTS: Exploratory retrospective cohort study of changes in outcomes associated with real-time CGM initiation, estimated using a difference-in-differences analysis. A total of 41 753 participants with insulin-treated diabetes (5673 type 1; 36 080 type 2) receiving care from a Northern California integrated health care delivery system (2014-2019), being treated with insulin, self-monitoring their blood glucose levels, and having no prior CGM use were included.
Initiation vs noninitiation of real-time CGM (reference group).
Ten end points measured during the 12 months before and 12 months after baseline: hemoglobin A1c (HbA1c); hypoglycemia (emergency department or hospital utilization); hyperglycemia (emergency department or hospital utilization); HbA1c levels lower than 7%, lower than 8%, and higher than 9%; 1 emergency department encounter or more for any reason; 1 hospitalization or more for any reason; and number of outpatient visits and telephone visits.
The real-time CGM initiators included 3806 patients (mean age, 42.4 years [SD, 19.9 years]; 51% female; 91% type 1, 9% type 2); the noninitiators included 37 947 patients (mean age, 63.4 years [SD, 13.4 years]; 49% female; 6% type 1, 94% type 2). The prebaseline mean HbA1c was lower among real-time CGM initiators than among noninitiators, but real-time CGM initiators had higher prebaseline rates of hypoglycemia and hyperglycemia. Mean HbA1c declined among real-time CGM initiators from 8.17% to 7.76% and from 8.28% to 8.19% among noninitiators (adjusted difference-in-differences estimate, -0.40%; 95% CI, -0.48% to -0.32%; P < .001). Hypoglycemia rates declined among real-time CGM initiators from 5.1% to 3.0% and increased among noninitiators from 1.9% to 2.3% (difference-in-differences estimate, -2.7%; 95% CI, -4.4% to -1.1%; P = .001). There were also statistically significant differences in the adjusted net changes in the proportion of patients with HbA1c lower than 7% (adjusted difference-in-differences estimate, 9.6%; 95% CI, 7.1% to 12.2%; P < .001), lower than 8% (adjusted difference-in-differences estimate, 13.1%; 95% CI, 10.2% to 16.1%; P < .001), and higher than 9% (adjusted difference-in-differences estimate, -7.1%; 95% CI, -9.5% to -4.6%; P < .001) and in the number of outpatient visits (adjusted difference-in-differences estimate, -0.4; 95% CI, -0.6 to -0.2; P < .001) and telephone visits (adjusted difference-in-differences estimate, 1.1; 95% CI, 0.8 to 1.4; P < .001). Initiation of real-time CGM was not associated with statistically significant changes in rates of hyperglycemia, emergency department visits for any reason, or hospitalizations for any reason.
In this retrospective cohort study, insulin-treated patients with diabetes selected by physicians for real-time continuous glucose monitoring compared with noninitiators had significant improvements in hemoglobin A1c and reductions in emergency department visits and hospitalizations for hypoglycemia, but no significant change in emergency department visits or hospitalizations for hyperglycemia or for any reason. Because of the observational study design, findings may have been susceptible to selection bias.
连续血糖监测(CGM)被推荐用于 1 型糖尿病患者;在胰岛素治疗的 2 型糖尿病患者中,CGM 的观察性证据不足。
估计实时 CGM 启动的临床结果。
设计、设置和参与者:对与实时 CGM 启动相关的结果变化进行探索性回顾性队列研究,使用差异差异分析进行估计。共有 41753 名接受北加州综合医疗服务系统(2014-2019 年)治疗的胰岛素治疗糖尿病患者(5673 型 1;36080 型 2)参与,他们接受胰岛素治疗,自我监测血糖水平,且无先前 CGM 使用史。
实时 CGM 的启动与非启动(参考组)。
基线前 12 个月和后 12 个月测量的 10 个终点:糖化血红蛋白(HbA1c);低血糖(急诊或住院治疗);高血糖(急诊或住院治疗);HbA1c 水平低于 7%、低于 8%和高于 9%;因任何原因而出现 1 次以上急诊就诊;因任何原因而出现 1 次以上住院治疗;以及门诊就诊次数和电话就诊次数。
实时 CGM 启动者包括 3806 名患者(平均年龄 42.4 岁[标准差 19.9 岁];51%为女性;91%为 1 型,9%为 2 型);非启动者包括 37947 名患者(平均年龄 63.4 岁[标准差 13.4 岁];49%为女性;6%为 1 型,94%为 2 型)。实时 CGM 启动者的基线前平均 HbA1c 低于非启动者,但实时 CGM 启动者的低血糖和高血糖发生率更高。实时 CGM 启动者的平均 HbA1c 从 8.17%下降到 7.76%,非启动者从 8.28%下降到 8.19%(调整后的差异差异估计值,-0.40%;95%置信区间,-0.48%至-0.32%;P <.001)。实时 CGM 启动者的低血糖发生率从 5.1%下降到 3.0%,而非启动者从 1.9%上升到 2.3%(差异差异估计值,-2.7%;95%置信区间,-4.4%至-1.1%;P =.001)。HbA1c 水平低于 7%(调整后的差异差异估计值,9.6%;95%置信区间,7.1%至 12.2%;P <.001)、低于 8%(调整后的差异差异估计值,13.1%;95%置信区间,10.2%至 16.1%;P <.001)和高于 9%(调整后的差异差异估计值,-7.1%;95%置信区间,-9.5%至-4.6%;P <.001)的患者比例,以及门诊就诊次数(调整后的差异差异估计值,-0.4;95%置信区间,-0.6 至-0.2;P <.001)和电话就诊次数(调整后的差异差异估计值,1.1;95%置信区间,0.8 至 1.4;P <.001)也有统计学显著变化。实时 CGM 的启动与因任何原因的高血糖、急诊就诊或住院治疗的发生率无统计学显著变化。
在这项回顾性队列研究中,与非启动者相比,医生选择的接受胰岛素治疗的糖尿病患者实时连续血糖监测的实时 CGM 启动者的血红蛋白 A1c 显著改善,低血糖导致的急诊就诊和住院治疗减少,但因任何原因导致的急诊就诊或住院治疗的高血糖或任何原因均无显著变化。由于观察性研究设计,研究结果可能容易受到选择偏倚的影响。