Clinical trial NCT00315991: Blood Glucose Awareness Training for Parents
Official title: Parent-Child Co-Regulation of Pediatric Diabetes, Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: BG perception
hypoglycemic awareness
pediatric T1DM
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Joslin Diabetes Center
First posted: 2006-04-19
Enrollment: 77
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of blood glucose level estimation
timeFrame: 70 trials over a one month period
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research
name: Linda Gonder-Frederick, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: