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临床试验/NCT07664293
NCT07664293已完成不适用

Comparison of the Safety and Efficacy of the Far Eastern Memorial Hospital Electronic Glucose Management System (eGMS) With Conventional Subcutaneous Basal-Bolus Insulin Protocol in Ordinary Ward Patients: A Prospective Randomized Controlled Trial

Far Eastern Memorial Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1

研究概览

简要总结

The purpose of this study is to compare the eGMS designed by FEMH with the usual insulin ordering protocol in the safety and efficacy of subcutaneous insulin therapy in ordinary ward.

详细描述

Both inpatient hyperglycemia and hypoglycemia increase the adverse effects of ordinary ward patients, including mortality rate, so the American Diabetes Association recommends that the blood glucose target for inpatients is 140 to 180 mg/dL. Previous studies found that the use of electronic glucose management system (eGMS) could increase the achievement of the goal. Currently, there are several eGMS on the market, such as Glucommander(Glytec,Greenville,SC)、EndoTool System(MD Scientific LLC,Charlotte,NC) and GlucoStabilizer(Medical Decision Network,Charlottesville,VA), although they were proved to improve in blood glucose management in hospitals, nurses still need to manually enter clinical parameters and each blood glucose data, causing a burden on medical staff.

Neither Glucommander nor EndoTool system considered vital signs, intravenous and partial intravenous nutrition infusion, diagnosis of hepatic, renal and heart failure, which would also affect the level of blood glucose. To our best knowledge, no similar eGMS has been developed in Asia or Taiwan. Our hospital is about to develop an easy-to-operate eGMS. This system can automatically obtain the patient's demographic characteristics, vital signs, daily diet and intake status, usage of anti-diabetic agents or other medications that affect the level of blood glucose, the ICD codes of hypoglycemia risk factors, and laboratory test results from the electronic medical records of the hospital. There is no need to manually input by the medical staff, and the recommended insulin dose will be updated and calculated continuously. The FEMH eGMS study will be developed in Feb. 2022.

The purpose of this study is to compare the eGMS designed by FEMH with the usual insulin ordering protocol in the safety and efficacy of subcutaneous insulin therapy in ordinary ward.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Patients in the same ward will be randomly assigned by computer in a ratio of 1:1 to the interventional group or the control group.

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 20 years
  • Type 2 diabetes mellitus
  • Required four-times-daily subcutaneous basal-bolus insulin during admission
  • At least two point-of-care glucose readings >180 mg/dL during admission

排除标准

  • Type 1 diabetes mellitus
  • Pregnancy
  • Gestational diabetes
  • Hyperosmolar hyperglycemic state or diabetic ketoacidosis at admission
  • Total parenteral nutrition
  • Treatment with intravenous insulin infusion (insulin pump)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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