Diabetes Mellitus, Type 1NCT00315991
Blood Glucose Awareness Training for Parents
A study testing Blood Glucose Awareness Training for Parents in people with Diabetes Mellitus, Type 1, run by University of Virginia at 2 sites in United States.
Trial summary
The purpose of this study is to test a training program for parents of children with T1DM. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Blood Glucose Awareness Training for Parents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Dec 2008
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent/Guardian with primary responsibility for a child's diabetes management
- Child with T1DM between the ages 6 - 11 years.
- Duration of child's diabetes > 1 year
- Routine self-testing of child's BG > 2x day
- Intention to remain in the study's geographical region for the next 5 months
- Have a computer at home
Who cannot join
- Significant comorbidity in the child that could interfere with BG awareness or psychosocial status
- Medications taken by the child that interfere with symptom perception
- Psychiatric disorder in a parent or child
- Cognitive deficits/learning disabilities in the child that might preclude ability to complete the study protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Joslin Diabetes Center
Boston, Massachusetts
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Parent-Child Co-Regulation of Pediatric Diabetes, Phase 2
The purpose of this study is to test a training program for parents of children with T1DM.
Read the detailed description
Successful diabetes management relies on a process of self-regulation in which treatment behavior is guided by feedback about changing blood glucose (BG) levels and decision-making. The processes involved in self-regulation have been studied extensively in adults with Type 1 Diabetes Mellitus (T1DM), leading to the development of sophisticated research tools that have significantly advanced our understanding and ability to predict clinical outcome. Additionally, this research has led to the development of a highly effective, empirically based,pyschobehavioral intervention, Blood Glucose Awareness Training (BGAT) that improves self-regulation and clinical outcome in adults with T1DM. Unfortunately, the processes involved in the self-regulation of pediatric diabetes have received virtually no empirical attention. The purpose of this project is to correct the scientific neglect of the self-regulation in pediatric diabetes by adapting the conceptual and methodological tools used in adult studies to investigate the process of diabetes regulation by school-aged children (6-11 years) with T1DM and their parents and to develop and test an intervention to enhance the skills critical to this process.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Blood Glucose Awareness Training for Parents
- Keywords
- BG perception, hypoglycemic awareness, pediatric T1DM
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Glucose Awareness Training for ParentsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| BGAT Intervention | Experimental | Blood Glucose Awareness Training for Parents Receives: Behavioral: Blood Glucose Awareness Training for Parents |
| Control | No intervention | Enter PDA data and complete questionnaires only. No intervention received. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of blood glucose level estimation
Parents and children asked to report symptoms and give an estimated bg level. Later compared to actual bg levels to give an accuracy rating.
Measured: 70 trials over a one month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Joslin Diabetes Center
- Responsible party
- Sponsor
- Investigators
- Linda Gonder-Frederick, Ph.D., Principal investigator, University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315991
- Sponsor's protocol ID
- 12202
- Status last verified
- Jan 2013
- First submitted
- 18 Apr 2006
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-Child Co-Regulation of Pediatric Diabetes, Phase 2
- ClinicalTrials.gov ID
- NCT00315991
- Acronym / sponsor ID
- 12202
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- BG perception, hypoglycemic awareness, pediatric T1DM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Joslin Diabetes Center
- Study start
- Apr 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Apr 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.
The purpose of this study is to test a training program for parents of children with T1DM.
Detailed description
Successful diabetes management relies on a process of self-regulation in which treatment behavior is guided by feedback about changing blood glucose (BG) levels and decision-making. The processes involved in self-regulation have been studied extensively in adults with Type 1 Diabetes Mellitus (T1DM), leading to the development of sophisticated research tools that have significantly advanced our understanding and ability to predict clinical outcome. Additionally, this research has led to the development of a highly effective, empirically based,pyschobehavioral intervention, Blood Glucose Awareness Training (BGAT) that improves self-regulation and clinical outcome in adults with T1DM. Unfortunately, the processes involved in the self-regulation of pediatric diabetes have received virtually no empirical attention. The purpose of this project is to correct the scientific neglect of the self-regulation in pediatric diabetes by adapting the conceptual and methodological tools used in adult studies to investigate the process of diabetes regulation by school-aged children (6-11 years) with T1DM and their parents and to develop and test an intervention to enhance the skills critical to this process.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BGAT Intervention | Experimental | Behavioral: Blood Glucose Awareness Training for ParentsBlood Glucose Awareness Training for Parents |
| Control | No intervention | –Enter PDA data and complete questionnaires only. No intervention received. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parent/Guardian with primary responsibility for a child's diabetes management
- Child with T1DM between the ages 6 - 11 years.
- Duration of child's diabetes > 1 year
- Routine self-testing of child's BG > 2x day
- Intention to remain in the study's geographical region for the next 5 months
Key exclusion criteria (4 listed)
- Significant comorbidity in the child that could interfere with BG awareness or psychosocial status
- Medications taken by the child that interfere with symptom perception
- Psychiatric disorder in a parent or child
- Cognitive deficits/learning disabilities in the child that might preclude ability to complete the study protocol.
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 for Parents | Behavioural | BGAT Intervention |
Primary outcome
Accuracy of blood glucose level estimation
Time frame: 70 trials over a one month period
Parents and children asked to report symptoms and give an estimated bg level. Later compared to actual bg levels to give an accuracy rating.
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 16 Jan 2013.
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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.
Linda Gonder-Frederick, Ph.D. principal investigator
University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research
2 sites 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 for Parents in people with Diabetes Mellitus, Type 1, run by University of Virginia at 2 sites 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 6 inclusion and 4 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 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Accuracy of blood glucose level estimation (time frame: 70 trials over a one month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2013.