Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001321639
Ethics application status
Approved
Date submitted
7/12/2014
Date registered
17/12/2014
Date last updated
19/11/2015
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)
U111111600503
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
Diabetes

Intervention/exposure
Study type
Interventional
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
Behaviour
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
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/12/2014
Actual
7/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment outside Australia
Country [1] 6511 0
New Zealand
State/province [1] 6511 0
Waikato

Funding & Sponsors
Funding source category [1] 290360 0
Charities/Societies/Foundations
Name [1] 290360 0
Waikato Medical Research Foundation
Country [1] 290360 0
New Zealand
Primary sponsor type
Hospital
Name
Waikato Regional Diabetes Service, Waikato DHB
Address
Private Bag 3200
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 289082 0
University
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
Approved
Ethics committee name [1] 292064 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 292064 0
Ethics committee country [1] 292064 0
New Zealand
Date submitted for ethics approval [1] 292064 0
Approval date [1] 292064 0
04/12/2014
Ethics approval number [1] 292064 0
14/CEN/181

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
+64212803204
Fax 53302 0
Email 53302 0
[email protected]
Contact person for public queries
Name 53303 0
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
+64212803204
Fax 53303 0
Email 53303 0
[email protected]
Contact person for scientific queries
Name 53304 0
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
+64212803204
Fax 53304 0
Email 53304 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.