Blood Glucose Awareness Training for Parents
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Purpose
The purpose of this study is to test a training program for parents of children with T1DM.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 1 |
Behavioral: Blood Glucose Awareness Training for Parents |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label |
| Official Title: | Parent-Child Co-Regulation of Pediatric Diabetes, Phase 2 |
- Accuracy of blood glucose level estimation [ Time Frame: 70 trials over a one month period ] [ Designated as safety issue: No ]Parents and children asked to report symptoms and give an estimated bg level. Later compared to actual bg levels to give an accuracy rating.
| Enrollment: | 77 |
| Study Start Date: | April 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BGAT Intervention
Blood Glucose Awareness Training for Parents
|
Behavioral: Blood Glucose Awareness Training for Parents |
|
No Intervention: Control
Enter PDA data and complete questionnaires only. No intervention received.
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations| United States, Massachusetts | |
| Joslin Diabetes Center | |
| Boston, Massachusetts, United States | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Principal Investigator: | Linda Gonder-Frederick, Ph.D. | University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research |
More Information
No publications provided
| Responsible Party: | University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00315991 History of Changes |
| Other Study ID Numbers: | 12202 |
| Study First Received: | April 18, 2006 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Virginia:
|
BG perception hypoglycemic awareness pediatric T1DM |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013