Blood Glucose Awareness Training for Parents

This study has been completed.
Sponsor:
Collaborator:
Joslin Diabetes Center
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT00315991
First received: April 18, 2006
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
Diabetes Mellitus, Type 1
Behavioral: Blood Glucose Awareness Training for Parents

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Parent-Child Co-Regulation of Pediatric Diabetes, Phase 2

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Accuracy of blood glucose level estimation [ Time Frame: 70 trials over a one month period ] [ Designated as safety issue: No ]
    Parents and children asked to report symptoms and give an estimated bg level. Later compared to actual bg levels to give an accuracy rating.


Enrollment: 77
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGAT Intervention
Blood Glucose Awareness Training for Parents
Behavioral: Blood Glucose Awareness Training for Parents
No Intervention: Control
Enter PDA data and complete questionnaires only. No intervention received.

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

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315991

Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Joslin Diabetes Center
Investigators
Principal Investigator: Linda Gonder-Frederick, Ph.D. University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research
  More Information

No publications provided

Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT00315991     History of Changes
Other Study ID Numbers: 12202
Study First Received: April 18, 2006
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
BG perception
hypoglycemic awareness
pediatric T1DM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014