Diabetes Mellitus, Type 1
Conditions
Keywords
BG perception, hypoglycemic awareness, pediatric T1DM
Brief summary
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.
Interventions
BEHAVIORALBlood Glucose Awareness Training for Parents
Sponsors
Joslin Diabetes Center
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of blood glucose level estimation | 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. |
Countries
United States
Outcome results
None listed