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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.).

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 groups in NCT01563887
Study groupRoleWhat they receive
DD.comExperimentalParticipants 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 + MIExperimentalParticipants 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.

  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.

    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.

  1. First posted27 Mar 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

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)
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

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.

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