The HEADWIND Study - Part 2

NCT04569630 | Completed

• 1 other identifier: HEADWIND 2
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

To analyse driving behavior of individuals with type 1 diabetes in eu- and progressive hypoglycaemia while driving in a real car. Based on the driving variables provided by the car 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; Car

Outcome Measures

Primary Outcomes (1)

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

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

  240 minutes

Secondary Outcomes (47)

• Change of swerving

  240 minutes

• Change of spinning

  240 minutes

• Change of velocity

  240 minutes

• Change of steer

  240 minutes

• Change of brake

  240 minutes

Study Arms (1)

Intervention group

EXPERIMENTAL

Other: Controlled hypoglycaemic state while driving

Interventions

Controlled hypoglycaemic state while driving OTHER

Participants will drive on a designated circuit with a real car on a test track accompanied by a driving instructor. Driving data will be recorded in 4 subsequent glycemic states using an adapted hypoglycemic clamp protocol: euglycemia (d1, 5-8 mmol/l), progressive hypoglycaemia (d2, declining from 4.5 to 2.5 mmol/l), stable hypoglycemia (d3, 2.0-2.5 mmol/l), and again in euglycaemia (d4, 5-8 mmol/l). Patients will be blinded to their glucose levels.

Intervention group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Active driving in the last 6 months.

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.
• 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

Sponsors & Collaborators

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

Study Sites (1)

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism

Bern, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia; Carney Complex

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Myxoma; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Heart Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Heart Diseases; Cardiovascular Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Abnormalities

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: September 17, 2020
• First Posted: September 30, 2020
• Study Start: October 1, 2020
• Primary Completion: May 27, 2021
• Study Completion: May 28, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

CH (1)