Type 1 Diabetes MellitusNCT00327210
Feasibility and Efficacy of Delivering Blood Glucose Awareness Training Over the Internet
A study testing Blood Glucose Awareness Training in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Blood Glucose Awareness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jul 2009
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not able to complete the Internet program in 12 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Viginia Health System
Charlottesville, Virginia, 22907
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Blood Glucose Awareness Training
- Keywords
- BGAT, Blood Glucose Awareness Training, Diabetes, T1DM, Internet, Web, Intervention, Treatment, Behavior, Education, Awareness
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Glucose Awareness TrainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| BGATHome | Experimental | Blood Glucose Awareness Training at Home Internet Intervention Receives: Behavioral: Blood Glucose Awareness Training |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Internet Evaluation
Measured: 12 weeks
Secondary outcomes (4)
Improved blood glucose awareness
Blood Glucose Diaries
Measured: 12 weeks
Reduced adverse events
Blood Glucose Diaries
Measured: 12 weeks
Improved psychological functioning
Hypo Fear Survey, Diabetes Quality of Life
Measured: 12 weeks
Improved knowledge
Diabetes Knowledge Scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startMay 2005
- Primary completionJul 2009
- Study completionJul 2009
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 Diabetes MellitusStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Daniel J Cox, Ph.D, Principal investigator, University of Virginia Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327210
- Sponsor's protocol ID
- 11593
- Status last verified
- Nov 2017
- First submitted
- 16 May 2006
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18477813
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Glucose Awareness Training Delivered Over the Internet (BGATHome.Com): Feasibility and Efficacy
- ClinicalTrials.gov ID
- NCT00327210
- Acronym / sponsor ID
- 11593
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- BGAT, Blood Glucose Awareness Training, Diabetes, T1DM, Internet, Web, Intervention, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- May 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 18 May 2006 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BGATHome | Experimental | Behavioral: Blood Glucose Awareness TrainingBlood Glucose Awareness Training at Home Internet Intervention |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Not able to complete the Internet program in 12 weeks.
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 |
|---|---|---|
| Blood Glucose Awareness Training | Behavioural | BGATHome |
Primary outcome
Feasibility
Time frame: 12 weeks
Internet Evaluation
4 secondary outcomes
Improved blood glucose awareness
Time frame: 12 weeks
Reduced adverse events
Time frame: 12 weeks
Improved psychological functioning
Time frame: 12 weeks
Improved knowledge
Time frame: 12 weeks
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 8 Nov 2017.
- Derived from this study: PubMed 18477813Cox 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.
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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 Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Glucose Awareness Training in people with Type 1 Diabetes Mellitus, 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 4 inclusion and 1 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 8 Nov 2017. 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?
Feasibility (time frame: 12 weeks). 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 NCT00327210, 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 8 Nov 2017.