Efficacy and Safety of the Artificial Intelligence-assisted Insulin Dose Adjustment System for Glycaemic Control in Patients With Type 2 Diabetes Mellitus in General Wards: a Multicentre, Single-blind, Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- time in target range (3.9-10.0 mmol/L )
研究概览
简要总结
Our study was a single-blind, randomised, controlled, multicentre study. The study was planned to enrol 142 patients with T2DM admitted to general wards who required subcutaneous insulin therapy. Participants were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence-assisted insulin decision system to adjust insulin doses for blood glucose control, and the other group received clinician-instituted insulin dose adjustments for blood glucose control. The effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups.
详细描述
Our study was a single-blind, randomised, controlled, multicentre study. The study was planned to enrol 142 patients with T2DM admitted to the general ward who required subcutaneous insulin therapy. Participants were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence-assisted insulin decision system to adjust insulin doses for blood glucose control, and the other group received clinician-instituted insulin dose adjustments for blood glucose control. The effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Diagnosis of type 2 diabetes mellitus > 3 months
- •Age≥18 years old
- •Receiving glucose-lowering management for at least 90 days
- •Blood glucose:7.8-22.2 mmol/L
- •Length of proposed hospitalisation ≥5 days.
排除标准
- •Type 1 diabetes mellitus, other special types of diabetes mellitus
- •BG>22.2 mmol/L, or acute complications of diabetes, such as diabetic ketoacidosis, diabetic hyperosmolar state
- •History of severe or repeated hypoglycaemia
- •BMI≥45 kg/m2
- •Pregnant and lactating women
- •Clinically relevant liver disease (established cirrhosis and portal hypertension)
- •Presence of severe renal disease (serum creatinine ≥3.0 mg/dL or estimated glomerular filtration rate <30 ml/min/1.73 m2)
- •Severe cardiac insufficiency
- •Patients undergoing corticosteroid therapy (equivalent to a prednisone dose >5 mg/day)
- •Psychiatric abnormalities or impaired cognitive function
- •Patients with severe oedema, infection, or peripheral blood circulation disorder
- •Patients with severe illness or patients to be transferred to ICU for treatment
- •Surgery of the heart or abdomen that may have a significant impact on the test is planned during hospitalisation
- •Expected to be NPO for an extended period
- •Any medical or psychological conditions, or medications that, in the doctor's judgment, could interfere with the results
- •Subjects who cannot comply with the protocol.
研究组 & 干预措施
Doctor group
doctor adjust insulin
干预措施: doctor's insulin dose adjustment (Other)
AI group
AI-assisted insulin dosage adjustment
干预措施: AI-assisted insulin dose adjustment model (Device)
结局指标
主要结局
time in target range (3.9-10.0 mmol/L )
时间窗: ≥3 days
Proportion of time in the target glucose range (TIR; 3.9-10.0 mmol/L) measured by CGM during the intervention period.
次要结局
- sensor glucose(≥3 days)
- Other/Serious Adverse Events(≥3 days)
- capillary blood sugar(≥3 days)
- insulin dosage(≥3 days)
- satisfaction score of doctors(after intervention)
- hypoglycaemic event(≥3 days)
- Length of hospitalisation(≥3 days)
- hyperglycaemic event(≥3 days)