Non-randomised, Controlled, Interventional Single-centre Study for the Design and Evaluation of an in Vehicle Hypoglycaemia Warning System in Diabetes - The HEADWIND Study Part 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the hypoglycemia warning system using in-vehicle data to detect hypoglycemia (blood glucose <3.9mmol/L) quantified as the area under the receiver operator characteristics curve (AUC ROC).
研究概览
简要总结
To analyse driving behavior of individuals with type 1 diabetes in eu- and mild hypoglycaemia using a validated research driving simulator. Based on the driving variables provided by the simulator the investigators aim at establishing algorithms capable of discriminating eu- and hypoglycemic driving patterns using machine learning classifiers.
详细描述
Hypoglycaemia is among the most relevant acute complications of diabetes mellitus. During hypoglycaemia physical, psychomotor, executive and cognitive function significantly deteriorate. These are important prerequisites for safe driving. Accordingly, hypoglycaemia has consistently been shown to be associated with an increased risk of driving accidents and is, therefore, regarded as one of the relevant factors in traffic safety. Therefore, this study aims at evaluating a machine-learning based approach using in-vehicle data to detect hypoglycemia during driving at an early stage.
During controlled eu- and hypoglycemia, participants with type 1 diabetes mellitus drive in a validated driving simulator while in-vehicle data are recorded. Based on this data, the investigators aim at building machine learning classifiers to detect hypoglycemia during driving.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Type 1 Diabetes mellitus as defined by WHO for at least 1 year or is confirmed C-peptide negative (<100pmol/l with concomitant blood glucose >4 mmol/l)
- •Subjects aged between 21-60 years
- •HbA1c ≤ 9.0 % based on analysis from central laboratory
- •Functional insulin treatment with insulin pump therapy or basis-bolus insulin for at least 3 months with good knowledge of insulin self-management
- •Passed driver's examination at least 3 years before study inclusion. Possession of a valid Swiss driver's license.
- •Active driving in the last 6 months before the study.
排除标准
- •Contraindications to the drug used to induce hypoglycaemia (insulin aspart), known hypersensitivity or allergy to the adhesive patch used to attach the glucose sensor
- •Women who are pregnant or breastfeeding
- •Intention to become pregnant during the study
- •Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- •Other clinically significant concomitant disease states as judged by the investigator (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Participation in another study with an investigational drug within the 30 days preceding and during the present study
- •Previous enrolment into the current study
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Total daily insulin dose >2 IU/kg/day.
- •Specific concomitant therapy washout requirements prior to and/or during study participation
- •Physical or psychological disease is likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator (especially coronary heart disease or epilepsy).
- •Current treatment with drugs known to interfere with metabolism (e.g. systemic corticosteroids, etc.) or driving performance (e.g. opioids, benzodiazepines)
- •Patients not capable of driving with the driving simulator or patients experiencing motion sickness during the simulator test driving session.
研究组 & 干预措施
Intervention group
干预措施: Controlled hypoglycaemic state while driving with a driving simulator (Other)
结局指标
主要结局
Diagnostic accuracy of the hypoglycemia warning system using in-vehicle data to detect hypoglycemia (blood glucose <3.9mmol/L) quantified as the area under the receiver operator characteristics curve (AUC ROC).
时间窗: 240 minutes
The machine learning model is developed and evaluated based on in-vehicle data generated in eu- and hypoglycemia. Detection performance of hypoglycemia is quantified as AUROC.
次要结局
- Change of electrodermal activity over the glycemic trajectory(240 minutes)
- Change of gaze coordinates over the glycemic trajectory.(240 minutes)
- Change of head pose over the glycemic trajectory.(240 minutes)
- Change of heart rate variability over the glycemic trajectory(240 minutes)
- CGM accuracy over the glycemic trajectory(240 minutes)
- Change in driving features over the glycemic trajectory.(240 minutes)
- Hypoglycemic symptoms over the glycemic trajectory.(240 minutes)
- Technology acceptance of the hypoglycemia warning system(240 minutes)
- Diagnostic accuracy of the hypoglycemia warning system using wearable data to detect hypoglycemia (blood glucose <3.9mmol/L) quantified as the area under the receiver operator characteristics curve (AUC ROC).(240 minutes)
- Diagnostic accuracy of the hypoglycemia warning system using wearable data and recordings of the CGM system to detect hypoglycemia (blood glucose <3.9mmol/L) quantified as sensitivity and specificity.(240 minutes)
- Change of heart rate over the glycemic trajectory(240 minutes)
- Time course of the hormonal response over the glycemic trajectory(Time Frame: 240 minutes)
- Self assessment of driving performance over the glycemic trajectory.(240 minutes)
- Diagnostic accuracy of the hypoglycemia warning system using in-vehicle data and recordings of the continous glucose monitoring (CGM) system to detect hypoglycemia (blood glucose <3.9mmol/L) quantified as sensitivity and specificity.(240 minutes)
- Incidence of Serious Adverse Events (SAEs)(2 weeks, from screening to close out visit in each participant)
- Incidence of Adverse Events (AEs)(2 weeks, from screening to close out visit in each participant)
- Emotional response to hypoglycemia warning system(240 minutes)