Blood Glucose Awareness Training for Parents

January 14, 2013 updated by: University of Virginia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States
        • Joslin Diabetes Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
70 trials over a one month period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

Joslin Diabetes Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

April 18, 2006

First Submitted That Met QC Criteria

April 18, 2006

First Posted (Estimate)

April 19, 2006

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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