The Efficacy and Safety of Degludec Insulin Use for Glycemic Control in Critically Ill Patients: A Prospective Interventional Study (Protocol)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- The percentage of blood glucose readings at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).
研究概览
简要总结
Background:
Dysglycemia in critically ill patients is common, where 40% to 54% of patients were found to be hyperglycemic on intensive care unit admission. Several randomized controlled trials (RCT) were conducted to address the importance of glycemic control during critical illness on patient's outcomes.
The American association of diabetes recommends initiation of insulin infusion for critically ill patients aiming to target glucose levels 140-180 mg/dl. However, several limitations prevent the use of insulin infusion in critically ill such as the requirements of frequent blood glucose measurement and nursing staff workload, which in turn led to the use of the subcutaneous rapid acting and basal insulin during critical illness. The evidence on the use of subcutaneous insulin therapy compared to insulin infusion is mainly derived from observational studies that showed conflicting results.
Multiple RCTs demonstrated the comparable efficacy of degludec versus glargine in blood glycemic control and better safety profile in terms of nocturnal hypoglycemia and severe hypoglycemia in the outpatient/inpatient diabetic population. Studies addressing the role, safety, and efficacy of degludec in critically ill patients are lacking.
Study aim:
To assess the effectiveness of using insulin degludec as basal insulin in conjunction with subcutaneous regular insulin sliding scale (ISS) in the glycemic control in critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and above
- •Newly admitted critically ill patients with diabetes and expected ICU stay ≥ 48 hours
- •Medical or surgical ICU patients
排除标准
- •Patients who were already started on insulin infusion based on physician discretion.
- •Postoperative patients with expected ICU stay less than 48 hours
- •Diabetic ketoacidosis or hyperosmolar hyperglycemic state.
- •Patients with Do-Not-Attempt-Resuscitation (DNAR) status or imminent plan to palliation due to terminal disease.
- •Refusal of the treating physician to enroll the patient into the study.
- •Patients with diabetes mellitus Type
- •Patients who already eating prior to study enrollment
研究组 & 干预措施
Degludec
干预措施: Degludec insulin (Drug)
结局指标
主要结局
The percentage of blood glucose readings at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).
时间窗: until stopping the intervention and up to 28 days
次要结局
- To determine the covariates associated with the development of hypoglycemia(During therapy and up to 28 days)
- To determine the covariates associated with failure to achieve target glycemic control(During therapy and up to 28 days)
- The average or mean blood glucose in the whole cohort(until stopping the intervention and up to 28 days)
- The rate of developing hypoglycemia during therapy(until stopping the intervention and up to 28 days)
- Glucose variability during therapy(until stopping the intervention and up to 28 days)
- The rate of 28-day Mortality(Censored at day 28)
- The proportions of patients achieving the target glycemic control(until stopping the intervention and up to 28 days)
- The time-spent at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).(until stopping the intervention and up to 28 days)
- Intensive care unit (ICU) length of stay(Censored at day 28)
研究者
Zainab Alduhailib
Consultant Critical Care Medicine
King Faisal Specialist Hospital & Research Center