The HEADWIND-Study

NCT04035993 | Completed

• 1 other identifier: HEADWIND
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

To analyse driving behavior of individuals with type 1 diabetes in eu- and progressive 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 neural networks (deep machine learning classifiers).

Conditions

Diabetes; Diabetes Mellitus, Type 1

Keywords

Automotive Technology; Hypoglycemia; Hypoglycaemia; Driving; Driving simulator

Outcome Measures

Primary Outcomes (1)

• Accuracy of the HEADWIND-model: Diagnostic accuracy of the hypoglycaemia warning system (HEADWIND) to detect hypoglycaemia (blood glucose <3.9mmol/l and <3.0mmol/l) quantified as the area under the receiver operator characteristics curve (AUC ROC).

  Accuracy of the HEADWIND-model will be assessed using driving data recorded in progressive hypoglycemia and driving data will be analysed using applied machine learning technology for hypoglycemia detection.

  240 minutes

Secondary Outcomes (38)

• Change of time driving over midline

  240 minutes

• Change of swerving

  240 minutes

• Change of spinning

  240 minutes

• Defining the glycemic level when driving performance is decreased

  240 minutes

• Driving performance before and after hypoglycemia

  240 minutes

Study Arms (1)

Intervention group

EXPERIMENTAL

Other: Controlled hypoglycaemic state while driving with a driving simulator

Interventions

Controlled hypoglycaemic state while driving with a driving simulator OTHER

Patients will arrive in the morning after an overnight fast. During the controlled hypoglycaemic state, participants will drive on a designated circuit using a driving simulator. Initially, euglycaemic state (5.0-8.0 mmol/L) will be kept stable and then blood glucose will be declined progressively targeting at a level between 2.0-2.5mmol/L by administering an insulin bolus. Glucose will be kept stable at the hypoglycaemic level for 30 minutes. Thereafter, it will be raised again and kept stable for another 30 minutes at an euglycaemic level between 5.0-8.0mmol/L. During the procedure, we will analyse counterregulatory hormones. Heart rate, skin conductance, CGM values, eye movement and facial expression, will be recorded by a smart-watch, a CGM device, an eye-tracker and an onboard camera, respectively. Participants will be blinded to the glucose values during the procedure. They will have to rate their symptoms and their performance on a 0-6 scale every 15 minutes.

Intervention group

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• DM1 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 21-50 years
• HbA1c ≤ 8.5 % based on analysis from central laboratory
• Functional insulin treatment with insulin pump therapy (CSII) or basis-bolus insulin for at least 3 months with good knowledge of insulin self-management

You may not qualify if:

• 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, statins etc.) or driving performance (e.g. opioids, benzodiazepines)
• Only for the main-study: Patients not capable of driving with the driving simulator or patients experiencing motion sickness during the simulator test driving session (at visit 2).

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• ETH Zurich: collaborator
• University of St.Gallen: collaborator

Study Sites (1)

University Department of Endocirnology, Diabetology, Clinical Nutrition and Metabolism

Bern, Switzerland

Location

Related Publications (1)

• Berube C, Lehmann VF, Maritsch M, Kraus M, Feuerriegel S, Wortmann F, Zuger T, Stettler C, Fleisch E, Kocaballi AB, Kowatsch T. Effectiveness and User Perception of an In-Vehicle Voice Warning for Hypoglycemia: Development and Feasibility Trial. JMIR Hum Factors. 2024 Jan 9;11:e42823. doi: 10.2196/42823.

  PMID: 38194257 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Christoph Stettler, Prof. MD

  Inselspital, Bern University Hospital, University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: July 29, 2019
• Study Start: October 7, 2019
• Primary Completion: July 2, 2020
• Study Completion: July 6, 2020
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

CH (1)