Safety & Efficacy study in kidney transplant patients of Smart Insulin Recommendation App (SIRA), a mobile based insulin dosing application
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 1. Improvement in glycemic control, measured as the percentage of blood glucose readings within the target range (e.g., 70–180 mg/dL).
研究概览
简要总结
This is a prospective, open-label study evaluating the safety and efficacy of InsulinRx, a precision insulin titration system, in managing postoperative hyperglycemia in kidney transplant patients with type 2 diabetes or new-onset hyperglycemia. The study includes 34 adult patients (17 per group) during their 4–5 day stay in the ICU. The primary endpoints are mean blood glucose levels and the percentage of readings within the target range (80–180 mg/dL), while secondary outcomes include incidence of hypoglycemia, hyperglycemia, glucose variability, postoperative complications, and ICU/hospital stay duration. With prior pilot data showing no hypoglycemia and 70% of glucose readings within range, the study aims to validate InsulinRx as a safe and effective tool to optimize glycemic control, reduce complications, and support clinical decision-making in a high-risk transplant population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
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 kidney transplant and admitted to the postoperative intensive care unit (ICU).
- •Diagnosed with: Pre-existing diabetes mellitus (type 2), 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
- •Participants will be excluded from the study if they meet any of the following criteria: Diagnosed with type 1 diabetes mellitus or other forms of diabetes requiring specialized insulin regimens.
- •Unable/ unwilling to give informed consent.
结局指标
主要结局
1. Improvement in glycemic control, measured as the percentage of blood glucose readings within the target range (e.g., 70–180 mg/dL).
时间窗: 4–5 days of ICU stay.
2. Mean blood glucose
时间窗: 4–5 days of ICU stay.
次要结局
- 1. Reduction in hypoglycemic episodes (blood glucose less than 70 mg/dL).(2. Reduction in severe hyperglycemia (blood glucose greater than 250 mg/dL).)
研究者
Dr Shyam B Bansal
Medanta, the Medicity