Safety & Efficacy Study of Smart Insulin Recommendation App (SIRA) for maintaining optimal glycemic control in Cardiac Surgery Patients with Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Primary Objectives:
研究概览
简要总结
This is a prospective, controlled, open-label study to evaluate the safety and efficacy of SIRA (Smart Insulin Recommendation App), a decision support tool which recommends insulin doses based on real time glucose data captured from glucometer in hospitalized patients with diabetes undergoing cardiac surgery. The study will compare glycemic outcomes, safety parameters, and workflow efficiency between patients managed using SIRA-guided insulin recommendations and those managed with standard insulin therapy protocols. The primary objective is to assess whether SIRA can improve time-in-target glucose range and reduce glycemic variability without increasing the risk of hypoglycemia.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 years or older
- •Undergoing cardiac surgery and admitted to the post operative cardiac intensive care unit (ICU)
- •Diagnosed with: Pre existing diabetes mellitus (type2) or New onset hyperglycemia during their ICU stay (defined as blood glucose levels greater that 180 mg dl on two or more occasions)
- •Expected to remain in the ICU for at least 4-5 days postoperatively
- •Able to provide informed consent or have a legally authorized representative provide consent on their behalf.
排除标准
- •Diagnosed with type 1 diabetes mellitus or other forms of diabetes requiring specialized insulin regimens
- •Unable or unwilling to give informed consent.
结局指标
主要结局
Primary Objectives:
1. To compare the efficacy of Smart Insulin Recommendation App (SIRA) in achieving optimal glycemic control (80 to 180mg/dl) as compared to standard operating procedures in hospitalized patients.
2. To compare the mean blood glucose between the two groups.
Primary Objectives:
时间窗: NA
1. To compare the efficacy of Smart Insulin Recommendation App (SIRA) in achieving optimal glycemic control (80 to 180mg/dl) as compared to standard operating procedures in hospitalized patients.
时间窗: NA
2. To compare the mean blood glucose between the two groups.
时间窗: NA
次要结局
- Secondary Outcomes:(1. Incidence of mild & severe hypoglycemia between the two groups.)
研究者
Dr Yatin Mehta
Medanta- The Medicity