COVID-19 studies are our top priority. For all other studies, we recommend commencing the registration process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission as we are experiencing 4 week turn-around time in review of submissions and resubmissions. We currently do not have the capacity to expedite reviews.

Note also there are additional delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hyperglycaemia and teen drivers with type 1 diabetes
Scientific title
The effect of blood glucose levels on driving behaviour and executive functioning in teenagers with type 1 diabetes
Secondary ID [1] 285795 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 293687 0
Condition category
Condition code
Metabolic and Endocrine 293986 293986 0 0

Study type
Description of intervention(s) / exposure
Participants’ performance on executive function and driving assessments will be assessed under euglycaemic and hyperglycaemic conditions. These will be compared to determine how blood glucose levels affect executive function and high level driving skills.

The order of the assessment sessions will be randomised. One assessment will be when the participant has a blood glucose level between 4 mmol/L – 9.4 mmol/L (euglycaemic) and the second when the participant has a blood glucose level above 15 mmol/L (hyperglycaemic). Each assessment will take approximately two hours. There will be a break of approximately two weeks between assessment sessions.

To increase a participants blood glucose to the hyperglycaemic range they will be given a standardised carbohydrate snack. Participants will be administered an insulin dose based on their Insulin Sensitivity Factor calculation to lower their blood glucose level to the euglycaemic range.

During both assessments, participants will complete objective executive functioning tasks and computer based driving tasks. Assessment of general cognitive ability, subjective ratings of executive functioning and driving behaviour will be completed when participants BGL is within the euglycaemic range

At the completion of the Hyperglycaemic session, the participants will be administered an insulin dose to lower blood glucose level to euglycaemic range using the participant’s Insulin Sensitivity Factor calculation.
Intervention code [1] 290761 0
Comparator / control treatment
Completion of executive functioning and driving assessments when blood glucose levels are in euglycaemic range (4.0 mmol/L - 9.4mmol/L)
Control group

Primary outcome [1] 293767 0
Executive Functioning
As assessed by CogState Battery (5 subtests), Delis-Kaplan Executive Function System (2 subtests), and the BRIEF-SR
Timepoint [1] 293767 0
Both the Euglycaemic and Hyperglycaemic sessions
Primary outcome [2] 293768 0
Driving Behaviour assessed by:
Stoplight task; Situation Awareness Test; and Hazard Perception Test
Timepoint [2] 293768 0
Both the Euglycaemic and Hyperglycaemic assessment sessions
Primary outcome [3] 293769 0
General Cognitive Functioning as assessed by
Weschler Abbreviated Scale of Intelligence
Timepoint [3] 293769 0
Euglycaemic Session
Secondary outcome [1] 311785 0
Anxiety and Depression as assessed by the Hospital Anxiety and Depression Scale
Timepoint [1] 311785 0
Euglycaemic state
Secondary outcome [2] 311786 0
Driving Attitudes as assessed by:
Driver Behaviour Questionnaire; Driver Attitude Questionnaire; and Driving Self-Evaluation
Timepoint [2] 311786 0
Hyperglycaemic session

Key inclusion criteria
1. Aged between 16 and 19 years
2. Diagnosis of Type 1 Diabetes (longer than 6 months)
3. Hold a restricted or full New Zealand driver licence
4. Drive regularly (> 4 times per week)
Minimum age
16 Years
Maximum age
19 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Pregnancy
2. Regular use of illicit substances
3. Episode of Diabetic Ketoacidosis in the previous 48 hours
4. Episode of documented severe hypoglycaemia requiring assistance in the previous 24 hours

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 6511 0
New Zealand
State/province [1] 6511 0

Funding & Sponsors
Funding source category [1] 290360 0
Name [1] 290360 0
Waikato Medical Research Foundation
Address [1] 290360 0
Peter Rothwell Academic Centre
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country [1] 290360 0
New Zealand
Primary sponsor type
Waikato Regional Diabetes Service, Waikato DHB
Private Bag 3200
Hamilton 3240
New Zealand
Secondary sponsor category [1] 289082 0
Name [1] 289082 0
School of Psychology, University of Waikato
Address [1] 289082 0
Private Bag 3105, University of Waikato, Hamilton 3240
Country [1] 289082 0
New Zealand

Ethics approval
Ethics application status
Ethics committee name [1] 292064 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 292064 0
Ministry of Health
Ethics Department
Level 13
Freyburg Building
20 Aitken Street
Wellington 6011
Ethics committee country [1] 292064 0
New Zealand
Date submitted for ethics approval [1] 292064 0
Approval date [1] 292064 0
Ethics approval number [1] 292064 0

Brief summary
This project aims to investigate the effect of hyperglycaemia (high blood glucose levels) on executive functioning, and higher-level driving skills in young people with Type 1 diabetes.
We hypothesise that acute hyperglycaemia will have a negative effect on participants performance on tests of executive functions and safe driving skills in young people with Type 1 diabetes compared to performance when blood glucose level is within the target range.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 53302 0
Dr Joanna McClintock
Address 53302 0
Waikato Regional Diabetes Service
Waikato District Health Board
Private Bag 3200
Hamilton 3240
Country 53302 0
New Zealand
Phone 53302 0
Fax 53302 0
Email 53302 0
Contact person for public queries
Name 53303 0
Dr Joanna McClintock
Address 53303 0
Waikato Regional Diabetes Service
Waikato District Health Board
Private Bag 3200
Hamilton 3240
Country 53303 0
New Zealand
Phone 53303 0
Fax 53303 0
Email 53303 0
Contact person for scientific queries
Name 53304 0
Dr Joanna McClintock
Address 53304 0
Waikato Regional Diabetes Service
Waikato District Health Board
Private Bag 3200
Hamilton 3240
Country 53304 0
New Zealand
Phone 53304 0
Fax 53304 0
Email 53304 0

No information has been provided regarding IPD availability
Summary results
No Results