Type 1 DiabetesNCT01563887
Identifying Driving Risk Factors in Type 1 Diabetes and Their Reduction Via Internet Program (DiabetesDriving.Com)
A study testing DD.com and DD.com + MI in people with Type 1 Diabetes and Hypoglycemia, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- What is being tested?
- DD.com and DD.com + MI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 568 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Identifying Driving Risk Factors in T1DM and Their Reduction Via Behavioral Intervention
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.
Read the detailed description
The investigators have demonstrated that drivers with Type 1 diabetes have at least twice as many collisions as their non-diabetic spouses, that about half of drivers with Type 1 diabetes have at least one hypoglycemic driving mishap a year, and 5% have at least six such events in a year. However, at this point the investigators can not accurately predict those individuals who will have hypoglycemia driving mishaps, which is one goal of this study. The investigators have also demonstrated that face-to-face behavioral interventions focusing on reducing the occurrence of hypoglycemia have lead to significantly fewer vehicular collisions and citations. The question arises whether such a behavioral intervention, specifically focused on reducing hypoglycemia while driving, can be effectively delivered over the internet.
Participants will first complete an Interest form. This questionnaire is used to determine an individual's presumed risk category (high or low risk). Research staff will use the risk category to randomly assign participants to one of four groups according to the randomization scheme. The four groups include: 1) Routine Care - low risk, 2) Routine Care - high risk, 3) DiabetesDriving.com (DD.com) where they will participate in an Internet intervention, 4) DiabetesDriving.com + Motivational Interviewing (MI) where subjects will receive the Internet intervention and two 60 minute MI sessions over the telephone. The MI sessions will take place once before and once following completion of the Internet intervention (within 7 days). This interview will focus on making explicit individuals' ambivalence around changing behavior.
Individuals assigned to the DD.com and DD.com+MI groups will complete 6 Cores, or classes over the internet, focusing on risk factors and prevention, detection, and management of hypoglycemia before and while driving. Each core will take approximately 30 minutes to complete. Core 0 is a tutorial on how to use the internet program. Core 1 focuses on how to use the Tool Kit; Core 2 focuses on how to be a safer driver in general; Core 3 focuses on how to prevent hypoglycemia from occurring while driving; Core 4 focuses on detecting and treating hypoglycemia during a drive; Core 5 focuses on how to maintain the improvements they have achieved in the previous Core over the next 12 months.
After completing a Core, individuals must wait a week before they can start the next Core. During this time individuals will complete at least three Daily Progress Notes, where they will rate their success at achieving their driving goals established in the previous Core. The Cores will take up to 8 weeks to complete before completing Driving Survey 2.
All participants will complete Driving Surveys and monthly driving diaries. The first Driving Survey (Driving Survey 0) will be available to participants as soon as they are consented. Driving Surveys will then be given at 2 and 14 months after submission of Driving Survey 0. Participants will also complete monthly driving diaries, where they will report their driving experiences for the full previous month. Monthly driving diaries will be available on the first day of the next full month 98 days (14 weeks) after completing the Driving Survey at month 2 and continue for 12 months. Twenty-six months after submitting Driving Survey 0, participants will be emailed for a two year follow-up. They will be asked to complete a brief questionnaire on driving outcomes (collisions, citations, etc.).
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Being tested
- DD.com, DD.com + MI
- Keywords
- Type 1 Diabetes, Hypoglycemia, Driving, Driving safety, Internet, Web, Treatment, Intervention
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DD.comBehavioural
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.
DD.com + MIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DD.com | Experimental | Participants in this arm will receive the DiabetesDriving.com internet intervention intended to help reduce their risk of being in a future collision. Receives: Behavioral: DD.com |
| DD.com + MI | Experimental | Participants 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. Receives: Behavioral: DD.com + MI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks and 62 weeks after submitting the first Driving Survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Cox, PhD, University of Virginia
- Investigators
- Daniel J Cox, Ph.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563887
- Sponsor's protocol ID
- 15360
- Other IDs
- 5R01DK028288-25
- Status last verified
- Oct 2021
- First submitted
- 29 Feb 2012
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28404657
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Driving Risk Factors in T1DM and Their Reduction Via Behavioral Intervention
- ClinicalTrials.gov ID
- NCT01563887
- Acronym / sponsor ID
- 15360
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- Type 1 Diabetes, Hypoglycemia, Driving, Driving safety, Internet, Web, Treatment, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators have demonstrated that drivers with Type 1 diabetes have at least twice as many collisions as their non-diabetic spouses, that about half of drivers with Type 1 diabetes have at least one hypoglycemic driving mishap a year, and 5% have at least six such events in a year. However, at this point the investigators can not accurately predict those individuals who will have hypoglycemia driving mishaps, which is one goal of this study. The investigators have also demonstrated that face-to-face behavioral interventions focusing on reducing the occurrence of hypoglycemia have lead to significantly fewer vehicular collisions and citations. The question arises whether such a behavioral intervention, specifically focused on reducing hypoglycemia while driving, can be effectively delivered over the internet.
Participants will first complete an Interest form. This questionnaire is used to determine an individual's presumed risk category (high or low risk). Research staff will use the risk category to randomly assign participants to one of four groups according to the randomization scheme. The four groups include: 1) Routine Care - low risk, 2) Routine Care - high risk, 3) DiabetesDriving.com (DD.com) where they will participate in an Internet intervention, 4) DiabetesDriving.com + Motivational Interviewing (MI) where subjects will receive the Internet intervention and two 60 minute MI sessions over the telephone. The MI sessions will take place once before and once following completion of the Internet intervention (within 7 days). This interview will focus on making explicit individuals' ambivalence around changing behavior.
Individuals assigned to the DD.com and DD.com+MI groups will complete 6 Cores, or classes over the internet, focusing on risk factors and prevention, detection, and management of hypoglycemia before and while driving. Each core will take approximately 30 minutes to complete. Core 0 is a tutorial on how to use the internet program. Core 1 focuses on how to use the Tool Kit; Core 2 focuses on how to be a safer driver in general; Core 3 focuses on how to prevent hypoglycemia from occurring while driving; Core 4 focuses on detecting and treating hypoglycemia during a drive; Core 5 focuses on how to maintain the improvements they have achieved in the previous Core over the next 12 months.
After completing a Core, individuals must wait a week before they can start the next Core. During this time individuals will complete at least three Daily Progress Notes, where they will rate their success at achieving their driving goals established in the previous Core. The Cores will take up to 8 weeks to complete before completing Driving Survey 2.
All participants will complete Driving Surveys and monthly driving diaries. The first Driving Survey (Driving Survey 0) will be available to participants as soon as they are consented. Driving Surveys will then be given at 2 and 14 months after submission of Driving Survey 0. Participants will also complete monthly driving diaries, where they will report their driving experiences for the full previous month. Monthly driving diaries will be available on the first day of the next full month 98 days (14 weeks) after completing the Driving Survey at month 2 and continue for 12 months. Twenty-six months after submitting Driving Survey 0, participants will be emailed for a two year follow-up. They will be asked to complete a brief questionnaire on driving outcomes (collisions, citations, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DD.com | Experimental | Behavioral: DD.comParticipants 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 | Experimental | Behavioral: DD.com + MIParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DD.comInternet 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. | Behavioural | DD.com |
| DD.com + MIPrior 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. | Behavioural | DD.com + MI |
Primary outcome
The change in the number of hypoglycemia-related driving mishaps
Time frame: 10 weeks and 62 weeks after submitting the first Driving Survey
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Derived from this study: PubMed 28404657Cox 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.
- The welcome page for the internet intervention.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Cox, Ph.D. principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DD.com and DD.com + MI in people with Type 1 Diabetes and Hypoglycemia, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the number of hypoglycemia-related driving mishaps (time frame: 10 weeks and 62 weeks after submitting the first Driving Survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01563887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.