成人2型糖尿病患者间歇性实时动态血糖监测的应用：一项试点随机对照试验的结果
Episodic Real-Time CGM Use in Adults with Type 2 Diabetes: Results of a Pilot Randomized Controlled Trial.
作者信息
Price David A, Deng Qianqian, Kipnes Mark, Beck Stayce E
机构信息
Dexcom, Inc., 6340 Sequence Dr., San Diego, CA, 92121, USA.
Diabetes & Glandular Disease Clinic, 5107 Medical Dr, San Antonio, TX, 78229, USA.
出版信息
Diabetes Ther. 2021 Jul;12(7):2089-2099. doi: 10.1007/s13300-021-01086-y. Epub 2021 Jun 4.
INTRODUCTION
Resistance to initiating insulin therapy is common for people with type 2 diabetes (T2D) using multiple oral agents, resulting in sustained poor glycemic control. We explored a non-pharmacologic option and examined whether adults with T2D and elevated hemoglobin A1c (HbA1c) who were using multiple, non-insulin antihyperglycemics could obtain glycemic benefit from limited, episodic use of real-time continuous glucose monitoring (rtCGM).
METHODS
A randomized, pilot trial enrolled patients with T2D who were using two or more non-insulin therapies and had HbA1c values of 7.8-10.5%. Following a baseline, 10-day, blinded CGM session, participants were randomized 2:1, rtCGM or self-monitoring of blood glucose (SMBG). Medication changes were not made during the 12-week study unless required for safety; benefits would result from lifestyle changes. The rtCGM group used unblinded rtCGM for three sessions at weeks 0, 4, and 8, and the control group managed diabetes with SMBG and wore blinded rtCGM at week 8. Glycemic endpoints were assessed.
RESULTS
Seventy participants were enrolled from eight North American sites and data were available from 68 (n = 45 rtCGM; n = 23 SMBG). Median (IQR) baseline HbA1c was 8.4 (0.8)% and 8.3 (1.2)% and median (IQR) change in HbA1c at week 12 was - 0.5 (1.3)% and - 0.2 (1.1)% for the rtCGM and SMBG groups, respectively (between-group difference p = 0.74). More than one-third (34.1%) of the rtCGM group vs 17.4% of the SMBG group reached the HbA1c goal of less than 7.5% at week 12 (between-group difference p = 0.12). Compared to run-in, mean (SD) time in range (TIR 70-180 mg/dL) at week 8 increased for the rtCGM group (56.3 [24.5]% vs 63.1 [25.5]%) while it decreased for the SMBG group (68.4 [21.5]% vs 55.1 [30.3]%). HbA1c reductions were not sustained at month 9.
CONCLUSION
In this pilot study, limited episodic rtCGM use in people failing multiple non-insulin therapies resulted in modest, short-term glycemic benefits.
引言
对于使用多种口服药物的2型糖尿病（T2D）患者来说，开始胰岛素治疗时出现抵抗现象很常见，这会导致血糖控制持续不佳。我们探索了一种非药物治疗方案，并研究了使用多种非胰岛素降糖药且糖化血红蛋白（HbA1c）升高的T2D成年人，能否通过有限的、间歇性使用实时连续血糖监测（rtCGM）获得血糖改善。
方法
一项随机试点试验纳入了正在使用两种或更多非胰岛素疗法且HbA1c值为7.8 - 10.5%的T2D患者。在进行为期10天的基线盲态CGM监测后，参与者按2:1随机分组，分别接受rtCGM或自我血糖监测（SMBG）。在为期12周的研究期间，除非出于安全需要，否则不进行药物调整；获益将来自生活方式的改变。rtCGM组在第0、4和8周进行三次非盲态rtCGM监测，对照组通过SMBG管理糖尿病，并在第8周佩戴盲态rtCGM。评估血糖终点指标。
结果
从北美8个地点招募了70名参与者，68名参与者有可用数据（rtCGM组n = 45；SMBG组n = 23）。rtCGM组和SMBG组的基线HbA1c中位数（IQR）分别为8.4（0.8）%和8.3（1.2）%，第12周时HbA1c的中位数（IQR）变化分别为 - 0.5（1.3）%和 - 0.2（1.1）%（组间差异p = 0.74）。rtCGM组超过三分之一（34.1%）的参与者在第12周达到了HbA1c低于7.5%的目标，而SMBG组为17.4%（组间差异p = 0.12）。与导入期相比，rtCGM组在第8周的平均（SD）血糖在目标范围内时间（TIR 70 - 180 mg/dL）增加（56.3 [24.5]% vs 63.1 [25.5]%），而SMBG组则下降（68.4 [21.5]% vs 55.1 [30.3]%）。第9个月时HbA1c的降低未持续。
结论
在这项试点研究中，对于多种非胰岛素疗法治疗失败的患者，有限的间歇性使用rtCGM带来了适度的短期血糖获益。
Zotero 插件