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Blood Glucose Awareness Training for Parents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00315991
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : January 16, 2013
Joslin Diabetes Center
Information provided by (Responsible Party):
University of Virginia

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Behavioral: Blood Glucose Awareness Training for Parents Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Parent-Child Co-Regulation of Pediatric Diabetes, Phase 2
Study Start Date : April 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00315991

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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
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Principal Investigator: Linda Gonder-Frederick, Ph.D. University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research

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Responsible Party: University of Virginia Identifier: NCT00315991    
Other Study ID Numbers: 12202
First Posted: April 19, 2006    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013
Keywords provided by University of Virginia:
BG perception
hypoglycemic awareness
pediatric T1DM
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases