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Feasibility and Efficacy of Delivering Blood Glucose Awareness Training Over the Internet

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Glucose Awareness Training
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring BGAT, Blood Glucose Awareness Training, Diabetes, T1DM, Internet, Web, Intervention, Treatment, Behavior, Education, Awareness

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Type 1 diabetes for at least one year. Access to the Internet. Routinely perform Self Monitoring of Blood Glucose at least three times a day. ≥ 21 years of age Exclusion Criteria: - Not able to complete the Internet program in 12 weeks.

Sites / Locations

  • University of Viginia Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BGATHome

Control

Arm Description

Blood Glucose Awareness Training at Home Internet Intervention

No intervention

Outcomes

Primary Outcome Measures

Feasibility
Internet Evaluation

Secondary Outcome Measures

Improved blood glucose awareness
Blood Glucose Diaries
Reduced adverse events
Blood Glucose Diaries
Improved psychological functioning
Hypo Fear Survey, Diabetes Quality of Life
Improved knowledge
Diabetes Knowledge Scale

Full Information

First Posted
May 16, 2006
Last Updated
November 6, 2017
Sponsor
University of Virginia
Collaborators
American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT00327210
Brief Title
Feasibility and Efficacy of Delivering Blood Glucose Awareness Training Over the Internet
Official Title
Blood Glucose Awareness Training Delivered Over the Internet (BGATHome.Com): Feasibility and Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Virginia
Collaborators
American Diabetes Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
BGATHome is an interactive, web-based training program designed to improve the ability of adults with Type 1 Diabetes to recognize, predict, treat, and avoid extreme blood glucose (BG) events. It was developed at the University of Virginia over the past 20 years with funding from the National Institutes of Health and the American Diabetes Association. BGATHome provides important knowledge about personal insulin use, food, and activity regimens that influence BG levels. Users of this program will learn to monitor and recognize the cues that signal hyper and hypoglycemic events, and enhance their ability to control these fluctuations.
Detailed Description
Interested subjects will be informed that they will be randomly assigned to either receive the BGATHome program or will be placed in a wait-list control group. Respondents will be informed that if they are in the control group, they are expected to complete the pre- and post-assessments (HHC and questionnaires), but once these are complete, they will be given free access to the BGATHome program. Respondents will be informed that being in the control group will delay their access to the program by approximately 5 months. A hand held computer (PDA) will be provided for use during this study. Subjects will be asked to first estimate their blood glucose level and enter this estimate into the PDA. They will then actually measure their blood glucose level and enter this actual value into the PDA also. This process of first estimating the blood glucose level and then taking an actual reading will be repeated 70 times during the 4-week period. The time estimated for this task is approximately 3 minutes for entering each estimate and measurement, or a total of 3.5 hours over the 4 weeks. The PDA device will be returned (postage paid) after the first 4 weeks of the study. At 12 weeks, the device will be sent to study subjects again and the process of obtaining data about blood glucose levels by first estimating and then taking an actual reading will be repeated over the next 4 weeks, as before. The PDA device will again be returned (postage paid) after 4 weeks of data collection. The total amount of time estimated to enter data into a PDA for this study is approximately 7 hours. Subjects will be asked to respond to a series of four questionnaires on the Internet, taking approximately 30-45 minutes. These questionnaires will be completed 3 times over the course of the study - before beginning the BGATHome program, at 12 weeks and at one year after completing the BGATHome program. The total time estimated to complete the three sets of questionnaires is approximately 2 hours, 15 minutes. Experimental subjects will be asked to complete a total of eight units of the BGATHome program, completing one unit a week except for the first week when two units will be completed. Each unit will take approximately one hour to complete. Subjects will have a maximum of 12 weeks to complete BGATHome. The total time is estimated at 8 hours. The wait-list control subjects will be offered access to the BGATHome program approximately five months after consenting to be in the study. They will then complete the series of four questionnaires on the Internet 12 weeks after using the BGATHome program. If the control subjects do not choose to use the program, a one year follow assessment will occur like the experimental subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
BGAT, Blood Glucose Awareness Training, Diabetes, T1DM, Internet, Web, Intervention, Treatment, Behavior, Education, Awareness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BGATHome
Arm Type
Experimental
Arm Description
Blood Glucose Awareness Training at Home Internet Intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Blood Glucose Awareness Training
Primary Outcome Measure Information:
Title
Feasibility
Description
Internet Evaluation
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Improved blood glucose awareness
Description
Blood Glucose Diaries
Time Frame
12 weeks
Title
Reduced adverse events
Description
Blood Glucose Diaries
Time Frame
12 weeks
Title
Improved psychological functioning
Description
Hypo Fear Survey, Diabetes Quality of Life
Time Frame
12 weeks
Title
Improved knowledge
Description
Diabetes Knowledge Scale
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes for at least one year. Access to the Internet. Routinely perform Self Monitoring of Blood Glucose at least three times a day. ≥ 21 years of age Exclusion Criteria: - Not able to complete the Internet program in 12 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Cox, Ph.D
Organizational Affiliation
University of Virginia Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Viginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22907
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18477813
Citation
Cox D, Ritterband L, Magee J, Clarke W, Gonder-Frederick L. Blood glucose awareness training delivered over the internet. Diabetes Care. 2008 Aug;31(8):1527-8. doi: 10.2337/dc07-1956. Epub 2008 May 13.
Results Reference
derived

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Feasibility and Efficacy of Delivering Blood Glucose Awareness Training Over the Internet

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