2型糖尿病住院患者餐后血糖控制的比较

IF 3.7 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Endocrine Practice Pub Date : 2025-03-01 DOI:10.1016/j.eprac.2024.11.015
Sara M. Alexanian MD, Michael C. Cheney MS, Nicole L. Spartano PhD, Jenny C. Bello-Ramos MD, Niyoti Reddy MD, Aamir Malik MD, Jonila Murati MD, Howard A. Wolpert MD, Devin W. Steenkamp MD
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引用次数: 0

摘要

目的:住院患者的高血糖与发病率和死亡率增加有关。对大多数患者来说,基础胰岛素治疗是首选的治疗方法。超快速与速效胰岛素对住院糖尿病患者的疗效尚未评估。我们评估了Fiasp与aspart (Novolog)作为基础胰岛素方案的一部分在安全网医院治疗非危重2型糖尿病患者的有效性和安全性的非劣效性。方法:这项前瞻性、开放标签、随机试验纳入137例非icu住院的糖尿病患者。受试者在睡前使用甘精,在餐后使用Fiasp或Novolog,并对胰岛素进行校正。受试者参加最少4次或最多6次膳食补贴。毛细管血糖用于胰岛素调节,Dexcom G6 Pro采集的盲法数据用于研究分析。主要终点是餐后4小时内血糖传感器在100-180 mg/dL范围内的时间(在106名餐后4小时≥4餐的参与者中进行评估)。结果:餐后4小时,在100-180 mg/dL范围内,Fiasp组为45%,Novolog组为36% (p=0.012;符合预定的非劣效性标准)。其他血糖指标在两组之间相似,处于低血糖范围的时间没有差异。结论:与Novolog相比,Fiasp对住院2型糖尿病患者的餐后血糖控制效果良好,低血糖发生率未增加。
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Comparing Postprandial Glycemic Control Using Fiasp vs Insulin Aspart in Hospitalized Patients With Type 2 Diabetes

Objective

Hyperglycemia in hospitalized patients is associated with increased morbidity and mortality. Basal-bolus insulin therapy is the treatment of choice for most patients. The efficacy of an ultrarapid vs rapid-acting insulin in hospitalized patients with diabetes has not been evaluated. We assessed noninferiority in efficacy and safety of Fiasp vs aspart (Novolog) as part of a basal-bolus insulin regimen in noncritically ill patients with type 2 diabetes in a safety-net hospital.

Methods

This prospective, open-label, randomized trial included 137 patients with diabetes admitted to a non-intensive care unit setting. Subjects were treated with glargine at bedtime and either Fiasp or Novolog for prandial and correction insulin. Subjects were enrolled for a minimum of 4 or maximum of 6 meal boluses. Capillary blood glucose was used for insulin adjustment and a blinded Dexcom G6 Pro captured data for study analysis. The primary endpoint was time spent in sensor glucose range 100-180 mg/dL in the 4-hour postprandial period (assessed among 106 participants with ≥ 4 meals with a 4-hour postprandial period). Time spent in hypoglycemic ranges (<70, <54, <40 mg/dL) was assessed for safety.

Results

Four-hour postprandial time in range 100-180 mg/dL was 45% in the Fiasp group vs 36% in the Novolog group (P = .012; meeting prespecified noninferiority criteria). Other glycemic metrics were similar between groups with no difference in time spent in hypoglycemic ranges.

Conclusion

Fiasp provides noninferior postprandial glucose control in hospitalized patients with type 2 diabetes when compared to Novolog with no increase in rates of hypoglycemia.
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来源期刊
Endocrine Practice
Endocrine Practice ENDOCRINOLOGY & METABOLISM-
CiteScore
7.60
自引率
2.40%
发文量
546
审稿时长
41 days
期刊介绍: Endocrine Practice (ISSN: 1530-891X), a peer-reviewed journal published twelve times a year, is the official journal of the American Association of Clinical Endocrinologists (AACE). The primary mission of Endocrine Practice is to enhance the health care of patients with endocrine diseases through continuing education of practicing endocrinologists.
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