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.
Looking for future studies?
Notify MeKey information
Conditions
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
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
Primary outcomes
-
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Advanced Hybrid Closed Loop System (AHCL) in Older Patients With Type 1 Diabetes Mellitus
NCT06236256
Autoimmune Diseases, Diabetes Mellitus
Ramat Gan, Israel
View Trial DetailsHypoglycemia Thresholds in Type 1 Diabetes
NCT07711275
Autoimmune Diseases, Diabetes Mellitus
Istanbul, Turkey (Türkiye)
View Trial DetailsPeer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions
NCT03938324
Anemia, Anemia, Hemolytic
Durham, North Carolina, United States
View Trial DetailsSubcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes
NCT07090824
Autoimmune Diseases, Diabetes Mellitus
Palo Alto, California, United States
View Trial Details