Feasibility and Efficacy of Delivering Blood Glucose Awareness Training Over the Internet
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/10/2017 |
| Start Date: | May 2005 |
| End Date: | July 2009 |
Blood Glucose Awareness Training Delivered Over the Internet (BGATHome.Com): Feasibility and Efficacy
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.
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.
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.
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.
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.
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