Blood Glucose Awareness Training for Parents

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

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Behavioral: Blood Glucose Awareness Training for Parents


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGAT Intervention<br>Blood Glucose Awareness Training for Parents | Behavioral: Blood Glucose Awareness Training for Parents<br> <br> |
| No Intervention: Control<br>Enter PDA data and complete questionnaires only. No intervention received. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BG perception, hypoglycemic awareness, pediatric T1DM