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Completed

NCT Number: NCT00315991

Blood Glucose Awareness Training for Parents

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

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Key information

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Glucose Awareness Training for Parents

Behavioral

Primary outcomes

  1. Accuracy of blood glucose level estimation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Joslin Diabetes Center

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 19, 2006
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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