Blood Glucose Awareness Training for Parents

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Behavioral: Blood Glucose Awareness Training for Parents

• Registration Number: NCT00315991
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-18
• Study First Submitted QC: 2006-04-18
• Study First Posted: 2006-04-19
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
BGAT Intervention	Blood Glucose Awareness Training for Parents	Blood Glucose Awareness Training for Parents

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States