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医院口服抗糖尿病药

2026年8月27日 更新者：Maya Fayfman、Emory University

住院糖尿病患者口服降糖药的使用

这项随机对照临床试验将评估在住院期间继续使用家庭口服抗糖尿病药物是否可以作为医院糖尿病管理中胰岛素治疗的安全有效替代方法。 该研究的主要结果是确定住院 2 型糖尿病 (T2D) 患者口服抗糖尿病药物和基础推注治疗之间的平均每日血糖浓度测量的血糖控制差异。

研究概览

地位

终止

条件

干预/治疗

详细说明

医院中的高血糖症很常见，并且与医院并发症、住院时间和死亡率的增加有关。 改善血糖控制已被证明可以改善住院时间、多器官衰竭、全身感染以及短期和长期死亡率。 来自专业组织的临床指南建议使用皮下 (SQ) 胰岛素作为 T2D 普通内科和外科患者血糖控制的首选疗法。 然而，这种方法是劳动密集型的，需要每天多次注射胰岛素，成本高，并且与医源性低血糖的显着风险相关

超过 75% 的 T2D 患者接受口服抗糖尿病药物 (OAD) 治疗，但由于缺乏来自随机对照试验的安全性和有效性数据，临床指南建议在住院期间停用 OAD。 目前的临床指南对 OADs 的使用提出了担忧，包括磺脲类药物引起的低血糖风险、噻唑烷二酮类药物引起的体液潴留和心力衰竭恶化，以及严重肾功能不全患者发生二甲双胍相关性乳酸酸中毒的风险。 然而，几项观察性研究报告称，与胰岛素方案相比，使用 OADs 可实现相似的血糖控制，而不会增加并发症的风险。 最近一项纳入 17,325 名 T2D 住院患者的观察性研究发现，与接受胰岛素治疗的患者相比，接受 OADs 治疗的患者血糖控制相似，并发症没有差异，低血糖发生率也没有增加。

本研究将评估在住院期间继续使用家庭口服抗糖尿病药是否可以作为胰岛素治疗的安全有效替代方法来管理住院的 T2D 患者的糖尿病。 对于一部分参与者（每组 50 名患者），将在研究期间放置 CGM 装置，以评估血糖控制和低血糖的参数。

研究类型

介入性

注册 (实际的)

85

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Emory University Hospital
      • Atlanta、Georgia、美国、30322
        • Emory University Hospital Midtown
      • Atlanta、Georgia、美国、30322
        • Grady Memorial Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 年龄在 18-80 岁之间接受普通内科和外科服务的男性或女性
  • T2D 接受 OAD 作为单一疗法或联合疗法的已知历史
  • 入院 BG < 250 mg/dl 或随机 BG <250 mg/dl 且未接受基础胰岛素
  • 接受 OAD 联合 GLP-1 受体激动剂 (GLP-1RA) 并且在过去三个月内 HbA1c <7.5% 的患者

排除标准：

  • 没有已知的糖尿病病史
  • 糖尿病酮症酸中毒的实验室证据
  • 有 1 型糖尿病病史的受试者（BMI < 25 提示需要胰岛素治疗或有糖尿病酮症酸中毒或酮尿症病史）
  • 满足基于家庭口腔治疗特定禁忌症的任何排除标准
  • 预计需要入住重症监护病房的急性危重疾病或心脏手术
  • 胃肠梗阻、无动力性肠梗阻或预计需要胃肠道抽吸
  • 内科或外科患者入院后或外科手术完成后预计将保持 NPO >24-48 小时
  • 肾功能受损（eGFR <30 毫升/分钟）
  • 目前口服或注射皮质类固醇治疗
  • 精神状况使受试者无法理解研究的性质和范围
  • 在研究登记时怀孕或哺乳的女性受试者
  • 入院时新发或近期（两周内）感染 2019 冠状病毒病 (COVID-19)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：单独口服抗糖尿病药物 (OAD)
除非有禁忌症，否则 OAD 将以相同的门诊剂量继续使用
药品：单独口服抗糖尿病药物
除非有禁忌症，否则 OADs 将以相同的门诊剂量继续使用。 参与者将被切换到他们在家中服用的药物类别中的首选药物。 OAD 的剂量调整将基于临床/实验室状态。 如果参与者被置于严格零口服 (NPO) 并且在注册后无法服用口服药物，则将举行 OAD。
其他名称：
  • 吡格列酮
  • 二甲双胍
  • 磺脲类
  • 二肽基肽酶 4 (DPP-4) 抑制剂
  • 钠-葡萄糖协同转运蛋白 2 (SGLT2) 抑制剂
药品：补充胰岛素
按照 BG >140 mg/dl 的补充/滑动量表护理方案补充（校正）赖脯胰岛素或门冬胰岛素。
其他名称：
  • 优泌乐
  • 诺和乐
设备：Continuous glucose monitoring (CGM)

A subset of participants will be randomized to take part in an optional study where a CGM device will be placed for the duration of the study. CGM reports will be reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment.

The Dexcom CGM is a small sensor that inserts just under the skin to continuously monitor glucose levels. Results are transmitted to the wearer's smartphone every five minutes.

其他名称：
  • 德康
有源比较器：基础推注胰岛素
基础胰岛素与甘精胰岛素或地特胰岛素和速效胰岛素（赖脯胰岛素/门冬胰岛素）将按照医院处方集使用。 OAD 和非胰岛素可注射抗糖尿病药物将在入院时停用。
药品：补充胰岛素
按照 BG >140 mg/dl 的补充/滑动量表护理方案补充（校正）赖脯胰岛素或门冬胰岛素。
其他名称：
  • 优泌乐
  • 诺和乐
药品：基础推注胰岛素
将根据医院处方集使用含有甘精胰岛素或地特胰岛素的基础胰岛素。
其他名称：
  • 甘精胰岛素
  • 地特米尔
设备：Continuous glucose monitoring (CGM)

A subset of participants will be randomized to take part in an optional study where a CGM device will be placed for the duration of the study. CGM reports will be reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment.

The Dexcom CGM is a small sensor that inserts just under the skin to continuously monitor glucose levels. Results are transmitted to the wearer's smartphone every five minutes.

其他名称：
  • 德康

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Mean Daily Blood Glucose (BG) Concentration
大体时间：During hospital stay (up to 10 days)
Mean daily BG concentration is compared between OADs and basal bolus therapy in hospitalized patients with type 2 diabetes (T2D).
During hospital stay (up to 10 days)

次要结果测量

结果测量
措施说明
大体时间
Number of Mild Hypoglycemic Events
大体时间：During hospital stay (up to 10 days)
Mild hypoglycemic events are defined as BG <70 mg/dl. Hypoglycemic events are assessed by point of care (POC) testing and continuous glucose monitoring (CGM).
During hospital stay (up to 10 days)
Number of Clinically Significant Hypoglycemic Events
大体时间：During hospital stay (up to 10 days)
Clinically significant hypoglycemic events are defined as BG <54 mg/dl. Hypoglycemic events are assessed by POC testing and CGM.
During hospital stay (up to 10 days)
Number of Severe Hypoglycemic Severe (<40 mg/dl) Events
大体时间：During hospital stay (up to 10 days)
Severe hypoglycemic events are defined as BG <40 mg/dl. Hypoglycemic events are assessed by POC testing and CGM.
During hospital stay (up to 10 days)
Percent of Blood Glucose Values Within Target Range Without Hypoglycemia
大体时间：During hospital stay (up to 10 days)
The percentage of BG values within the target range of 70-180 mg/dl and without hypoglycemia is compared between study arms.
During hospital stay (up to 10 days)
Number of Episodes of Hyperglycemia After the First Day of Treatment
大体时间：During hospital stay (up to 10 days)
The number of episodes of hyperglycemia (BG > 280 mg/dl) after the first day of treatment is compared between study arms.
During hospital stay (up to 10 days)
Units Per Day of Insulin
大体时间：During hospital stay (up to 10 days)
The units of insulin administered per day is compared between study arms.
During hospital stay (up to 10 days)
Number of Patients Using Specific Oral Antidiabetic Drugs (OADs) During Hospitalization
大体时间：During hospital stay (up to 10 days)
The number of participants using specific oral antidiabetic drugs (OADs) during hospitalization use was recorded. Some participants used more than one OAD.
During hospital stay (up to 10 days)
Number of Patients on OADs Requiring Insulin Rescue Therapy
大体时间：During hospital stay (up to 10 days)
The number of patients on OADs requiring insulin rescue therapy was recorded
During hospital stay (up to 10 days)
Number of Episodes of Treatment Failure
大体时间：During hospital stay (up to 10 days)
Treatment failure is defined as mean daily BG > 240 mg/dl or 3 consecutive BG > 240 mg/dl.
During hospital stay (up to 10 days)
Glycemic Variability in Participants Receiving CGM Monitoring
大体时间：During hospital stay (up to 10 days)
Glycemic variability is measured using the coefficient of variation
During hospital stay (up to 10 days)
Percentage of Time Above BG Target Range (>180 mg/dl) in Participants Receiving CGM Monitoring
大体时间：During hospital stay (up to 10 days)
The percentage of time above BG target range (>180 mg/dl) is assessed in participants receiving CGM monitoring.
During hospital stay (up to 10 days)
Percentage of Time in BG Target Range (70-180 mg/dl) in Participants Receiving CGM Monitoring
大体时间：During hospital stay (up to 10 days)
The percentage of time in the BG target range (70-180 mg/dl) is assessed in participants receiving CGM monitoring.
During hospital stay (up to 10 days)
Percentage of Time Below BG Target Range (BG <70 mg/dl) in Participants Receiving CGM Monitoring
大体时间：During hospital stay (up to 10 days)
The percentage of time below BG target range (BG <70 mg/dl) is assessed in participants receiving CGM monitoring.
During hospital stay (up to 10 days)
Number of Hospital Complications
大体时间：During hospital stay (up to 10 days)
Hospital complications are assessed as a composite variable including infectious, renal, pulmonary, neurologic, cardiovascular complications, and mortality.
During hospital stay (up to 10 days)
In-hospital Mortality
大体时间：During hospital stay (up to 10 days)
In-hospital mortality is compared between study arms.
During hospital stay (up to 10 days)
Number of Individual Hospital Complications
大体时间：Up to 40 days (hospital stay plus 30 days after discharge)
Number of individual hospital complications is compared between study arms. The specific complications assessed for this outcome include acute respiratory failure, acute renal failure (incremental rise in creatinine by 0.5 mg/dL from baseline), infection during hospitalization not felt to be present on admission (including wound infection, urinary tract infection, bacteremia), myocardial infarction, cardiac arrhythmia, congestive heart failure, and cardiac arrest.
Up to 40 days (hospital stay plus 30 days after discharge)
Hospital Costs
大体时间：During hospital stay (up to 10 days)
Total hospital costs will be compared between study arms.
During hospital stay (up to 10 days)
Length of Hospital Stay
大体时间：During hospital stay (up to 10 days)
Length of hospital stay, in days, is compared between study arms. Participants were engaged in study activities for up to 10 days during hospitalization and the total number of days of hospitalization was obtained from medical records.
During hospital stay (up to 10 days)
Costs for Diabetes Specific Therapies
大体时间：During hospital stay (up to 10 days)
Costs for diabetes specific therapies (including insulin, oral agents, and cost of injection administration) will be compared between study arms.
During hospital stay (up to 10 days)
Number of Hospital Re-admissions
大体时间：within 30 days of hospital discharge
Number of hospital re-admissions within 30 days of hospital discharge are compared between study arms.
within 30 days of hospital discharge
Number of Emergency Room Visits
大体时间：within 30 days of hospital discharge
Number of emergency room visits within 30 days of hospital discharge is compared between study arms.
within 30 days of hospital discharge
Number of Participants Requiring ICU Care
大体时间：During hospital stay (up to 10 days)
The number of participants transferred to the ICU is compared between study arms.
During hospital stay (up to 10 days)
Nursing Antihyperglycemic Drug Preference Survey
大体时间：Day of hospital discharge (up to 10 days)
The nurse who provided the most care for the participant during hospitalization completed a 7-item survey assessing antihyperglycemic drug preference. Nurses indicate if they agree or disagree with statements related to patient outcomes, workload requirements of insulin therapy, and perceived usefulness and safety of OADs. A summary score is not calculated for this qualitative survey. The number of nurses agreeing with each item are presented here.
Day of hospital discharge (up to 10 days)
Patient Antihyperglycemic Drug Preference Survey
大体时间：Day of hospital discharge (up to 10 days)
Participants completed a 2 to 5-item survey assessing preferences of antihyperglycemic medications while hospitalized. Participants indicate if they agree or disagree with statements about OAD and insulin use during hospital stays, timely administration of insulin, and concerns about low blood sugar. The number of participants agreeing with the survey item are presented here. A summary score is not calculated for this qualitative survey.
Day of hospital discharge (up to 10 days)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Emory University

合作者

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

调查人员

  • 首席研究员：Maya Fayfman, MD、Emory University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年8月7日

初级完成 (实际的)

2025年4月11日

研究完成 (实际的)

2025年4月11日

研究注册日期

首次提交

2020年6月2日

首先提交符合 QC 标准的

2020年6月2日

首次发布 (实际的)

2020年6月4日

研究记录更新

最后更新发布 (实际的)

2026年8月31日

上次提交的符合 QC 标准的更新

2026年8月27日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB00117027
  • 1K23DK124647-01 (美国 NIH 拨款/合同)
  • 2025P013073 (其他标识符：Emory IRB)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

在去标识化（文本、表格、数字和附录）后，作为本文报告结果基础的个人参与者数据将可供共享。

IPD 共享时间框架

个人参与者数据将在文章发表后 3 个月至 5 年内可供共享。

IPD 共享访问标准

个人参与者数据将可供提供方法论合理建议的研究人员共享。 该提案应发送至 maya.fayfman@emory.edu。 要获得访问权限，数据请求者需要签署数据访问协议。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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