Identifying Driving Risk Factors in Type 1 Diabetes and Their Reduction Via Internet Program (DiabetesDriving.Com)
2 other identifiers
interventional
568
1 country
1
Brief Summary
This study will recruit drivers with Type 1 diabetes from across the U.S. and assign them to four groups based on their presumed risk level- routine care low risk, routine care high risk, or to one of two Internet interventions focused on reducing hypoglycemia driving. All subjects will be followed for two years to determine whether and which intervention was most effective at reducing hypoglycemia related driving collisions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 29, 2012
CompletedFirst Posted
Study publicly available on registry
March 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 5, 2021
October 1, 2021
2.7 years
February 29, 2012
October 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in the number of hypoglycemia-related driving mishaps
Driving Surveys will be completed prior to study initiation, immediately after the intervention is finished, and again in one year. Monthly Driving Diaries will be completed each month for the year after the intervention finishes beginning 14 weeks after submitting the first Driving Survey.
10 weeks and 62 weeks after submitting the first Driving Survey
Study Arms (2)
DD.com
EXPERIMENTALParticipants in this arm will receive the DiabetesDriving.com internet intervention intended to help reduce their risk of being in a future collision.
DD.com + MI
EXPERIMENTALParticipants will receive the DiabetesDriving Internet intervention and two 60 minute Motivational Interview (MI) sessions over the telephone. The MI sessions will take place once before and once following completion of the Internet intervention. This interview will focus on making explicit individual's ambivalence around changing behavior.
Interventions
Internet intervention in which participants will complete 6 Cores, or classes over the internet, focusing on risk factors and prevention, detection, and management of hypoglycemia before and while driving.
Prior to starting and immediately after finishing the DiabetesDriving.com internet intervention, a one hour motivational interview will be conducted with participants. Internet intervention in which participants will complete 6 Cores, or classes over the internet, focusing on risk factors and prevention, detection, and management of hypoglycemia before and while driving.
Eligibility Criteria
You may qualify if:
- Have been diagnosed with Type 1 diabetes for at least one year
- Started taking insulin less than a year after being diagnosed with Type 1 diabetes
- Measure blood glucose at least twice a day
- Legal and valid driver's license
- Drives greater than 5,000 per year
- Regular access to the Internet, either through family computer or another readily accessible computer
- Age 18 - 70 years
- English speaker
You may not qualify if:
- Type 2 diabetes
- Does not take insulin
- Does not drive
- Does not have legal and valid driver's license
- Does not have routine access to the internet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22908, United States
Related Publications (1)
Cox DJ, Gonder-Frederick LA, Singh H, Ingersoll KS, Banton T, Grabman JH, Schmidt K, Clarke W. Predicting and Reducing Driving Mishaps Among Drivers With Type 1 Diabetes. Diabetes Care. 2017 Jun;40(6):742-750. doi: 10.2337/dc16-0995. Epub 2017 Apr 12.
PMID: 28404657DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel J Cox, Ph.D.
University of Virginia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Psychiatry and NB Sciences
Study Record Dates
First Submitted
February 29, 2012
First Posted
March 27, 2012
Study Start
February 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
October 5, 2021
Record last verified: 2021-10