Study to Assess the Efficacy and Safety of Insulin Titration System Based on Deep Learning on Glucose Control in Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- mean daily blood glucose concentration
研究概览
简要总结
This is an open-labeled, one-arm intervention trial to access the effect and safety of the Insulin Titration System Based on Deep Learning in patients with Type 2 Diabetes Mellitus.
详细描述
The study enrolls 13 patients with Type 2 Diabetes in Zhongshan Hospital who are on treatment with insulin. After screening for the inclusion and exclusion criteria, eligible patients will receive insulin dosage titration set by the Insulin Titration System Based on Deep Learning in the intervention trial. The goal of insulin therapy was to achieve preprandial capillary blood glucose between 5.6-7.8 mmol/L and postprandial capillary glucose less than 10.0mmol/L. All patients are studied for 5 consecutive days or untill hospital discharge. For each patient, capillary glucose concentration was measured at 7 time points of fasting, after breakfast, before and after lunch, before and after dinner, and before bedtime a day using Glucometer (Glupad, Sinomedisite, China). Capillary glucose measurements were performed by the nurse staff according to standard procedures with a point-of-care testing device, which is integrated into the HIS system. And continuous glucose monitoring (CGM) was performed using flash glucose monitoring (Abbott Freestyle Libre, USA) placed on the upper left arm. This study will be conducted in the Department of Endocrinology, Zhongshan Hospital,Fudan University.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •age of 18-75 years
- •HbA1c between 7.0% and 11.0%.
排除标准
- •subjects with acute complications of diabetes, such as ketoacidosis or hyperglycemic hyperosmolar state;
- •BMI ≥ 45kg/m2;
- •women who are pregnant or breast-feeding;
- •subjects with severe cardiac, hepatic, renal diseases; subjects with any psychiatric or psychological diseases;
- •subjects with severe edema, infections or peripheral circulation disorders, receiving surgery during hospitalization;
- •subjects who could not comply with the protocol
结局指标
主要结局
mean daily blood glucose concentration
时间窗: 5 days
For each patient, capillary glucose concentration was measured at 7 time points of fasting, after breakfast, before and after lunch, before and after dinner, and before bedtime a day using Glucometer (Glupad, Sinomedisite, China). Capillary glucose measurements were performed by the nurse staff according to standard procedures with a point-of-care testing device, which is integrated into the HIS system. The primary outcome is the difference in glycemia control as measured by mean daily blood glucose concentration during the intervention period.
次要结局
- glucose concentration below range (3.0-3.8 mmol/L or <3.0 mmol/L)(5 days)
- glycemic variability(5 days)
- glucose concentration in target range (TIR) of 3.9-10.0 mmol/L(5 days)
- glucose concentration above range (10.1-13.9 mmol/L or >13.9 mmol/L)(5 days)
研究者
Xiaoying Li
Professor
Shanghai Zhongshan Hospital