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Trial registered on ANZCTR


Registration number
ACTRN12617000781347p
Ethics application status
Submitted, not yet approved
Date submitted
24/05/2017
Date registered
29/05/2017
Date last updated
29/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing blood glucose related driving mishaps among adults with type 1 diabetes
Scientific title
Reducing blood glucose related driving mishaps among adults with type 1 diabetes: feasibility and initial efficacy of a low-cost online educational program and in-car tool-kit intervention
Secondary ID [1] 292037 0
ADEA RM31669
Universal Trial Number (UTN)
U1111-1196-8812
Trial acronym
DiabetesDriving-Australia (DDA)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 303429 0
Condition category
Condition code
Metabolic and Endocrine 302841 302841 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PROCEDURE


First month:

Participants will be asked to fill in an online survey, which will take approximately 30 minutes. They will receive a blood glucose meter and test strips in the post and will be asked to use this meter for checking their blood glucose before driving (as per current national guidelines). We will also provide them with a GPS device in the vehicle that they normally drive. This device will provide information regarding what times they are driving during the day. We will not use any location data generated by this device and such data will be deleted upon its return to ACBRD. Its sole purpose is to provide accurate data on the driving times.


Second month:

Participants will be randomly allocated to either the intervention or control groups.

If they are allocated to the control group:

They will be asked to continue their normal routine. At the end of the second month they will be asked to complete an online survey (30 minutes). The vehicle usage logging device and blood glucose meter will be returned via post. Participants in this control group will be given an opportunity to view a brief (30 minute) online hypo / diabetes management strategies unit at the end of the study (see details below).

If they are allocated to the intervention group:

They will be provided with a small tool-kit to keep in their car. This tool-kit will consist of a pre-drive checklist, rapid-acting and long-acting glucose sources, blood glucose driving benchmark keychain and stickers, and a blood glucose meter. The purpose of the tool-kit is to help support drivers who are managing their diabetes with insulin and will include such things as rapid-acting and long-acting glucose sources and a pre-driving checklist. Before using this tool-kit they will also be required to view a brief (30 minute) online hypo / diabetes management strategies unit, which will introduce the tool-kit and its purpose in supporting anticipation, prevention, detection and treatment of hypoglycaemia while driving.


A member of the study team will contact them to make sure they have received the tool-kit and to provide advice on how to incorporate it into their daily driving routine. At the end of the second month them will be asked to complete an online survey (30 minutes). The GPS device and blood glucose meter will be returned via post.


Intervention code [1] 298164 0
Behaviour
Comparator / control treatment
Participants will be randomly allocated to either the intervention or control groups.

If they are allocated to the control group:

They will be asked to continue their normal routine. At the end of the second month they will be asked to complete an online survey (30 minutes). The vehicle usage logging device and blood glucose meter will be returned via a post. Participants in this control group will be given an opportunity to view a brief (30 minute) online hypo / diabetes management strategies unit at the end of the study.
Control group
Active

Outcomes
Primary outcome [1] 302240 0
Primary outcome measure: Number of blood glucose related driving mishaps over a six-month period since intervention completion.

Assessment: Participants will be asked to complete monthly online driving mishap diaries during this period. Driving mishaps will be defined as collisions, moving vehicle violations, severe hypoglycemia while driving, loss of vehicle control, automatic driving (finding themselves at a destination with no awareness of the drive), and instances of impaired driving in which someone else took over driving.
Timepoint [1] 302240 0
Six-month post intervention completion.
Secondary outcome [1] 335254 0
Secondary outcome measure: Consistency of pre-driving blood glucose checks during the eight week assessment period.

Assessment: A car usage logger will timestamp participant vehicle usage over this period. The blood glucose meter supplied by the study team will timestamp any blood glucose checks performed by the driver. This will allow the latency between blood glucose checks and driving to be documented objectively
Timepoint [1] 335254 0
This data will be collected over two four-week assessments. The first is a four week baseline assessment period. The second is a four week intervention or control assessment period.
Secondary outcome [2] 335255 0
Secondary outcome measure: Self-assessed risky driving behaviour.

Assessment: Diabetic Driving Assessment scale (DDAS) and the Risk Assessment of Diabetic Drivers (RADD) questionnaires will be used to score driver behaviour.
Timepoint [2] 335255 0
This data will be collected at the start of the first month (week one) and at the end of the second month (week eight).
Secondary outcome [3] 335256 0
Secondary outcome measure: Hypoawareness

Assessment: The Gold score, a brief measure of impaired hypoawareness will be used to describe participants in terms of their hypoawareness .

Timepoint [3] 335256 0
This data will be collected at the start of the first month (week one) and at the end of the second month (week eight).
Secondary outcome [4] 335314 0
Secondary outcome measure: Severe hypoglycaemia incidence

Assessment: The Hypoglycaemia Awareness Questionnaire (HypoA-Q), a validated measure of frequency and severity of hypoglycaemia, will be used to describe participants in terms of their hypoglycaemia history.
Timepoint [4] 335314 0
This data will be collected at the start of the first month (week one) and at the end of the second month (week eight).

Eligibility
Key inclusion criteria
Inclusion criteria:
Adults (aged 25-65 years) with T1D diagnosed for at least 12 months or more; living in Australia; Ability to speak, read and write in English; Legal and valid driver's license (averaging at least 8000km annually); Drive regularly to work (at least 3 times weekly) in the same car; Report two or more BG-related driving mishaps in the past two years
Minimum age
25 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
Pregnancy or lactation or Severe comorbidity or mental illness


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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
As a pilot, no power calculations have been undertaken. Data will inform a larger RCT. Estimating a 20% dropout/incomplete data, we will recruit a minimum of 60 participants to achieve a sample of N=50.

The analysis will test the primary hypothesis that the number of blood glucose related driving mishaps will differ at a six-month follow up between participants in the DDA intervention group compared to those in routine care.

The group difference in mean latency between checking blood glucose and driving will be explored as a secondary hypothesis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296569 0
Charities/Societies/Foundations
Name [1] 296569 0
Australian Diabetes Educators Association (ADEA)
Address [1] 296569 0
The Research Foundation
PO Box 163
Woden
ACT 2606
Country [1] 296569 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
Locked Bag 200000
Geelong
VIC 3220
Country
Australia
Secondary sponsor category [1] 295523 0
None
Name [1] 295523 0
Address [1] 295523 0
Country [1] 295523 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297785 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 297785 0
Deakin University Locked Bag 20000. Geelong VIC 3220
Ethics committee country [1] 297785 0
Australia
Date submitted for ethics approval [1] 297785 0
23/01/2017
Approval date [1] 297785 0
Ethics approval number [1] 297785 0

Summary
Brief summary
Brief summary

Background

Australia drivers are required to stop driving for at least six weeks if they experience a severe hypoglycaemic event (requiring the assistance of another person for recovery). Australian fitness to drive guidelines indicate that specialist support should be available during this time to assist in the individual’s assessment and their potential return to driving. However, at present there are no structured education programs in place to assist these drivers when they return to driving, or pre-emptively, to minimize the risk of a hypoglycaemia-related driving incident.

Objectives
This project will develop an Australian version of the DiabetesDriving.com intervention, a low-cost educational program specifically aimed towards at-risk drivers with type 1 diabetes.

Study Plan
This is a pilot randomized controlled trial (RCT) conducted in Australia.

The number of blood glucose related driving mishaps is the primary outcome. Secondary outcomes include self-assessed risky driving behaviour and the frequency of pre-driving blood glucose checks. The latter is relevant as current guidelines require drivers to check their blood glucose level before driving.

As a pilot, no power calculations have been undertaken. Data will inform a larger RCT. Estimating a 20% dropout/incomplete data, we will recruit a minimum of 60 participants to achieve a sample of 50.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75106 0
Dr Steven Trawley
Address 75106 0
The Australian Centre for Behavioural Research in Diabetes
206 Queensberry Street, Carlton, VIC 3053
Country 75106 0
Australia
Phone 75106 0
+61 (0)3 8648 1844
Fax 75106 0
Email 75106 0
strawley@acbrd.org.au
Contact person for public queries
Name 75107 0
Dr Steven Trawley
Address 75107 0
The Australian Centre for Behavioural Research in Diabetes
206 Queensberry Street, Carlton, VIC 3053
Country 75107 0
Australia
Phone 75107 0
+61 (0)3 8648 1844
Fax 75107 0
Email 75107 0
strawley@acbrd.org.au
Contact person for scientific queries
Name 75108 0
Dr Steven Trawley
Address 75108 0
The Australian Centre for Behavioural Research in Diabetes
206 Queensberry Street, Carlton, VIC 3053
Country 75108 0
Australia
Phone 75108 0
+61 (0)3 8648 1844
Fax 75108 0
Email 75108 0
strawley@acbrd.org.au

No data has been provided for results reporting
Summary results
Not applicable