search
Back to results

Identifying Driving Risk Factors in Type 1 Diabetes and Their Reduction Via Internet Program (DiabetesDriving.Com)

Primary Purpose

Type 1 Diabetes, Hypoglycemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DD.com
DD.com + MI
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Hypoglycemia, Driving, Driving safety, Internet, Web, Treatment, Intervention

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Have been diagnosed with Type 1 diabetes for at least one year
  2. Started taking insulin less than a year after being diagnosed with Type 1 diabetes
  3. Measure blood glucose at least twice a day
  4. Legal and valid driver's license
  5. Drives greater than 5,000 per year
  6. Regular access to the Internet, either through family computer or another readily accessible computer
  7. Age 18 - 70 years
  8. English speaker

Exclusion Criteria:

  1. Type 2 diabetes
  2. Does not take insulin
  3. Does not drive
  4. Does not have legal and valid driver's license
  5. Does not have routine access to the internet

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DD.com

DD.com + MI

Arm Description

Participants in this arm will receive the DiabetesDriving.com internet intervention intended to help reduce their risk of being in a future collision.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 29, 2012
Last Updated
October 4, 2021
Sponsor
University of Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT01563887
Brief Title
Identifying Driving Risk Factors in Type 1 Diabetes and Their Reduction Via Internet Program (DiabetesDriving.Com)
Official Title
Identifying Driving Risk Factors in T1DM and Their Reduction Via Behavioral Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Hypoglycemia
Keywords
Type 1 Diabetes, Hypoglycemia, Driving, Driving safety, Internet, Web, Treatment, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
568 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DD.com
Arm Type
Experimental
Arm Description
Participants in this arm will receive the DiabetesDriving.com internet intervention intended to help reduce their risk of being in a future collision.
Arm Title
DD.com + MI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DD.com
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DD.com + MI
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in the number of hypoglycemia-related driving mishaps
Description
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.
Time Frame
10 weeks and 62 weeks after submitting the first Driving Survey

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Cox, Ph.D.
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28404657
Citation
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.
Results Reference
derived
Links:
URL
http://diabetesdriving.com
Description
The welcome page for the internet intervention.

Learn more about this trial

Identifying Driving Risk Factors in Type 1 Diabetes and Their Reduction Via Internet Program (DiabetesDriving.Com)

We'll reach out to this number within 24 hrs