Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05183191
Other study ID # HEADWIND 3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 29, 2021
Est. completion date March 3, 2022

Study information

Verified date May 2022
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date March 3, 2022
Est. primary completion date March 3, 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years to 60 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Other:
Controlled hypoglycaemic state while driving with a driving simulator
Participants arrive in the morning after an overnight fast. During the controlled hypoglycaemic state, participants drive on a designated circuit using a driving simulator. Initially, a euglycaemic state (5.0-8.0 mmol/L) is kept stable and blood glucose is then progressively declined targeting at a level between 3.0-3.5 mmol/L by administering insulin. Blood glucose is kept stable in the hypoglycaemic range for 30 minutes. Thereafter, blood glucose is raised again and kept stable for another 30 minutes at an euglycaemic level between 5.0-8.0mmol/L. During the procedure, the investigators analyse counterregulatory hormones. Heart rate, skin conductance, CGM values, eye movement and facial expression are recorded by a smart-watch, a CGM device, an eye-tracker and an onboard camera, respectively. Participants are blinded to the blood glucose values during the procedure and have to rate their symptoms and their driving performance on a 0-6 scale every 15 minutes.

Locations

Country Name City State
Switzerland University Department of Endocrinology, Diabetology, Clinical Nutrition and Metabolism Bern

Sponsors (3)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne ETH Zurich, University of St.Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 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. 240 minutes
Secondary 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). The machine learning model is developed and evaluated based on wearable data recorded in eu- and hypoglycemia. Detection performance of hypoglycemia is quantified as AUROC. 240 minutes
Secondary 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. The CGM device is in use during controlled eu- and hypoglycemia. Detection performance of hypoglycemia is quantified as sensitivity and specificity. 240 minutes
Secondary 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. The CGM device is in use during controlled eu- and hypoglycemia. Detection performance of hypoglycemia is quantified as sensitivity and specificity. 240 minutes
Secondary Change in driving features over the glycemic trajectory. Driving signals are recorded using a driving simulator. 240 minutes
Secondary Change of gaze coordinates over the glycemic trajectory. Gaze coordinates are recorded using an eye-tracker device. 240 minutes
Secondary Change of head pose over the glycemic trajectory. Head pose (position/rotation) are recorded using an eye-tracker device. 240 minutes
Secondary Change of heart rate over the glycemic trajectory Heart rate is recorded using a holter-ECG device and wearables. 240 minutes
Secondary Change of heart rate variability over the glycemic trajectory Heart rate variability is recorded using a holter-ECG device and wearables. 240 minutes
Secondary Change of electrodermal activity over the glycemic trajectory Electrodermal activity is recorded using wearables. 240 minutes
Secondary Hypoglycemic symptoms over the glycemic trajectory. Hypoglycemic symptoms are rated using a validated questionnaire (minimum score = 0, maximum score = 48, a higher score means more symptoms) 240 minutes
Secondary Time course of the hormonal response over the glycemic trajectory Epinephrine, norepinephrine, glucagon, cortisol and growth hormone are measured at pre-defined time points. Time Frame: 240 minutes
Secondary Self assessment of driving performance over the glycemic trajectory. Participants rate their driving performance on a 7-point Lickert Scale (lower value means poorer driving performance). 240 minutes
Secondary CGM accuracy over the glycemic trajectory CGM values will be recorded using a CGM sensor (Dexcom G6). Venous blood glucose is considered as the reference. Accuracy will be quantified using mean absolute relative difference (MARD) from the gold-standard and using the Clarke error grid. 240 minutes
Secondary Incidence of Adverse Events (AEs) Adverse Events will be recorded at each study visit. 2 weeks, from screening to close out visit in each participant
Secondary Incidence of Serious Adverse Events (SAEs) Serious Adverse Events will be recorded at each study visit. 2 weeks, from screening to close out visit in each participant
Secondary Emotional response to hypoglycemia warning system Physiological response is measured using an electro-dermal activity sensor (skin conductance) and eye tracker (eye blinks). Self-reported emotional response is assessed with scales (e.g., valence, arousal, annoyance, sense of urgency). 240 minutes
Secondary Technology acceptance of the hypoglycemia warning system Technology acceptance is measured with user experience questionnaires, such as the Unified Technology Acceptance and Use of Technology Questionnaire from Venkatesh et al. (2012) and free words associations. 240 minutes
See also
  Status Clinical Trial Phase
Completed NCT05594446 - Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
Completed NCT03975309 - DHS MIND Metabolomics
Completed NCT01855399 - Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes N/A
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Recruiting NCT04984226 - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD Phase 2
Recruiting NCT05007990 - Caregiving Networks Across Disease Context and the Life Course
Active, not recruiting NCT04420936 - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program N/A
Recruiting NCT03549559 - Imaging Histone Deacetylase in the Heart N/A
Completed NCT04903496 - Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
Completed NCT01437592 - Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects Phase 1
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT03390179 - Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Recruiting NCT05294822 - Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes N/A
Completed NCT04427982 - Dance and Diabetes/Prediabetes Self-Management N/A
Completed NCT02356848 - STEP UP to Avert Amputation in Diabetes N/A
Completed NCT03292185 - A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects Phase 1
Active, not recruiting NCT05477368 - Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes N/A
Completed NCT04496401 - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus Phase 4