Study to Assess the Efficacy and Safety of iNCDSS Assisted Insulin Dosage Titration System on Glucose Control in Type 2 Diabetes Mellitus Patients : a Muticenter, Single-blind, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Time in target glucose range
研究概览
简要总结
This is a multi-center, single-blind, parallel group, randomized controlled trial to access the effect and safety of the Artificial Intelligence Assisted Insulin Titration System (iNCDSS) in patients with Type 2 Diabetes Mellitus.
详细描述
As one of the most common treatments for diabetes inpatients, insulin regimens often vary due to different physicians. Since 2016, Zhongshan Hospital has set up the Internet-based glucose management system (iGMS) to monitor plasma glucose of diabetes patients, and further set up an Artificial Intelligence Assisted Insulin Titration System (iNCDSS) to recommend insulin regime in 2019. Previous single-center clinical trial (NCT04053959) have indicated the efficacy and safety of iNCDSS in glycemic management in patients with type 2 diabetes.
This multi-center study enrolls 142 patients with Type 2 Diabetes from three sites who are on treatment of diabetes for at least 3 months. They will be randomly allocated into 2 groups at a ratio of 1:1 after screening for the inclusion and exclusion criteria. Patients in the Intervention group (iNCDSS group) receive insulin regimen set by iNCDSS and patients in Regular treatment regime group receive insulin regimen recommended by endocrinologists.
This study will be conducted in the Department of Endocrinology in Shanghai Zhongshan Hospital, Shanghai fifth People's Hospital, Shanghai Xuhui Central Hospital, and will consist of a 5-day intervention period. Patient allocation will be stratified by HbA1c and sites. The primary endpoint is the time in target glucose range during the trial period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Men or women aged 18 and above years old;
- •Subjects who had been diagnosed with type 2 diabetes;
- •Subjects who are on diabetes treatment for at least 3 months;
- •HbA1c: 7.0%-11.0%.
排除标准
- •Subjects with acute complications of diabetes such as ketoacidosis or hyperglycemic hyperosmolar state;
- •Subjects who change the insulin regimens during hospitalization;
- •BMI ≥ 45kg/m2;
- •Women who are pregnant or nursing;
- •Subjects with severe cardiac, hepatic, renal or general diseases;
- •Subjects with psychiatric disorders or impaired cognitive function;
- •Subjects with severe edema, infections or peripheral circulation disorders;
- •Patients treated with surgery during hospitalization;
- •Subjects that are, in the judgement of the investigator, unlikely to comply with the protocol.
研究组 & 干预措施
iNCDSS group
Artificial intelligence assisted insulin titration system group
干预措施: iNCDSS based insulin regime (Drug)
Routine treatment group
Physician decided insulin titration group
干预措施: routine insulin treatment regime (Drug)
结局指标
主要结局
Time in target glucose range
时间窗: During 5-day intervention
The well-controlled blood glucose level is defined as the time of sensor glucose measurements in targeted range (3.9-10 mmol/L)
次要结局
- Proportion of time in which the blood glucose level is over 10 mmol/L(During 5-day intervention)
- Proportion of hypoglycemia(During 5-day intervention)
- Daily insulin dose(During 5-day intervention)
研究者
Xiaoying Li
Director
Shanghai Zhongshan Hospital