None listed
Conditions
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.
Interventions
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 n
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.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
25 Years to 65 Years
Healthy volunteers
No
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
Exclusion criteria
Exclusion criteria: Pregnancy or lactation or Severe comorbidity or mental illness
Outcome results
None listed