Sliding Scale Insulin vs Basal-Bolus Insulin Therapy in Long-Term Care: A 21-Day Randomized Controlled Trial Comparing Efficacy, Safety and Feasibility
Sliding Scale Insulin vs Basal-Bolus Insulin Therapy in Long-Term Care: A 21-Day Randomized Controlled Trial Comparing Efficacy, Safety and Feasibility
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DOI：
10.1016/j.jamda.2015.08.015
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发表时间：
2016-03-01
影响因子：
7.6
通讯作者：
Norkus, Edward P.
中科院分区：
文献类型：
--
作者：
Dharmarajan, Thiruvinvamalai S.;Mahajan, Dheeraj;Norkus, Edward P.
前言：滑动比例胰岛素(SSI)疗法仍然是长期护理(LTC)中治疗2型糖尿病的一种常见的胰岛素疗法，尽管目前的建议不支持目前的治疗形式。缺乏关于基础胰岛素(B-BI)在疗养院居民中的有效性和安全性的随机试验数据可能排除了这种形式的胰岛素在长期TC环境中的应用。本研究通过对老年养老院住院老人进行为期21天的干预试验，对SSI(对照)和B-BI(干预)的疗效进行了比较。方法：美国有14家长期护理机构参与，110名2型糖尿病住院患者自愿参加；35名纳入标准不合格，75名签署知情同意书，11名出院/住院或撤回同意；报告了来自参与者的数据。最近的空腹血糖(FBG)、血红蛋白A1c和化学指标都得到了测定。每天记录四次血糖读数(早餐、午餐、晚餐和睡前)、口服降血糖药物、胰岛素剂量和变化，以及所有不良事件/严重不良事件，包括与血糖控制相关的[低血糖(70 mg/dL)和高血糖(200 mg/dL)发作]和那些无关的不良事件。结果：疗养院居民80+/-8岁(标准差)，66%的女性参与；对照组和干预组的年龄、性别、种族分布、合并症和试验前3天的平均空腹血糖水平相似(均P>；0.05)。在研究结束时，B-BI志愿者的3天平均空腹血糖水平显著低于试验前(P=.0231)，而SSI参与者的3天平均空腹血糖水平没有变化(P>；0.05)。在试验期间，两组参与者的低血糖、高血糖、其他不良事件以及与血糖控制无关的住院(严重不良事件)的发生率相似(均P>；0.05)。结论：与SSI治疗相比，B-BI治疗21天后的平均空腹血糖水平显著降低；两组患者的低血糖和高血糖发生率相似。在LTC环境下，改用B-BI治疗是可行、安全和有效的。(C)2016年AMDA--急性后和长期护理医学学会。
Introduction: Sliding scale insulin (SSI) therapy remains a common means of insulin therapy in long-term care (LTC) for the management of type 2 diabetes mellitus, despite current recommendations not supportive of the form of therapy today. Lack of randomized trial data on the efficacy and safety of basalbolus insulin (B-BI) therapy in nursing home residents may have precluded this form of insulin administration in the LTC setting. Our study is a comparison of the efficacy of SSI (control) and B-BI (intervention) therapies during a 21-day intervention trial in older nursing home residents.Methods: Fourteen LTC facilities in the US participated; 110 residents with type 2 diabetes volunteered to participate; 35 failed inclusion criteria, 75 signed informed written consent, and 11 were discharged to home/hospital or withdrew consent; data from 64 participants are reported. Recent fasting blood glucose (FBG), hemoglobin A1c, and chemistries were obtained. Four glucose readings (prior to breakfast, lunch, dinner, and bedtime), oral antiglycemic drug, and insulin doses and changes, and all adverse events/serious adverse events, both those related to glucose control [hypoglycemic (< 70 mg/dL) and hyperglycemic (>200 mg/dL) episodes] and those unrelated, were recorded daily. Patients were randomized to either remain on SSI or be shifted to the B-BI group.Results: Nursing home residents 80 +/- 8 (standard deviation) years, 66% female participated; Control and Intervention participants had similar age, gender, race distributions, comorbidity, and 3-day average pretrial FBG levels (all P >.05). At study end, B-BI volunteers had significantly lower 3-day average FBG levels vs pretrial (P =.0231) while SSI participants had no change in 3-day average FBG (P >.05). During the trial, participants from both groups had similar rates of hypoglycemia, hyperglycemia, other adverse events, and hospitalizations (serious adverse events) unrelated to glucose control (all P >.05).Conclusions: B-BI therapy produced significantly lower average FBG levels after 21 days compared with SSI therapy; both groups had similar rates of hypo-and hyperglycemia. Switching to B-BI therapy is feasible, safe, and effective in the LTC setting. (c) 2016 AMDA - The Society for Post-Acute and Long-Term Care Medicine.