Clinical trial · Interventional
The HEADWIND Study - Part 4
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 IV
NCT05308095CI-TRIAL-00062806completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To analyse driving behavior of individuals with type 1 diabetes in eu- and mild hypoglycaemia while driving in a real car. Based on the in-vehicle variables, the investigators aim at establishing algorithms capable of discriminating eu- and hypoglycaemic driving patterns using machine learning classifiers.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes | — | UNRESOLVED | — |
| Diabetes Mellitus, Type 1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Controlled hypoglycaemic state while driving | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention group
- interventionNames
- Other: Controlled hypoglycaemic state while driving
Primary outcomes (1)
- measure
- Diagnostic accuracy of the hypoglycaemia warning system using in-vehicle data to detect hypoglycaemia quantified as the area under the receiver operating characteristics curve (AUROC).
- timeFrame
- 240 minutes
- description
- The machine learning model is developed and evaluated based on in-vehicle data generated in eu- and hypoglycaemia. Detection performance of hypoglycaemia is quantified as AUROC.
Secondary outcomes (20)
- measure
- Diagnostic accuracy of the hypoglycaemia warning system using wearable data to detect hypoglycaemia quantified as the area under the receiver operating characteristics curve (AUROC).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent as documented by signature * Type 1 Diabetes mellitus as defined by WHO for at least 1 year or confirmed C-peptide negative (\<100pmol/l with concomitant blood glucose \>4 mmol/l) * Age between 21-60 years * HbA1c ≤ 9.0 % * Functional insulin treatment with good knowledge of insulin self-management * Passed driver's examination at least 3 years before study inclusion. Possession of a valid, definitive Swiss driver's license. * Active driving in the last 6 months. 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. * Pregnancy or intention to become pregnant during the course of the study, lactating women or lack of safe contraception * Other clinically significant concomitant disease states as judged by the investigator * Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator * Renal failure * Hepatic dysfunction * Coronary heart disease * Other cardiovascular disease * Epilepsy * 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 * Total daily insulin dose \>2 IU/kg/day * Specific concomitant therapy washout requirements prior to and/or during study participation * Current treatment with drugs known to interfere with metabolism or driving performance
References
Publications (1)
- DERIVEDBerube C, Maritsch M, Lehmann VF, Kraus M, Feuerriegel S, Zuger T, Wortmann F, Stettler C, Fleisch E, Kocaballi AB, Kowatsch T. Multimodal In-Vehicle Hypoglycemia Warning for Drivers With Type 1 Diabetes: Design and Evaluation in Simulated and Real-World Driving. JMIR Hum Factors. 2024 Apr 18;11:e46967. doi: 10.2196/46967. PMID 38635313