Blood Glucose Awareness Training for Parents

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Parent-Child Co-Regulation of Pediatric Diabetes, Phase 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315991
• Other study ID #: 12202
• Status: Completed
• Phase: N/A
• First received: April 18, 2006
• Last updated: January 14, 2013
• Start date: April 2006
• Est. completion date: December 2008

Study information

• Verified date: January 2013
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test a training program for parents of children with T1DM.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• Blood Glucose Awareness Training for Parents

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	70 trials over a one month period	No