An interventional study of Developmental Demands and Distress Reduction in Type 1 Diabetes Mellitus, sponsored by Stanford University. Completed at 4 sites in United States. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2019-11-12.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
The primary objective of this project is to examine the impact of a continuous glucose monitoring (CGM) intervention on health and psychological outcomes in young children with type 1 diabetes (T1D).
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 92 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be eligible for the study, a child must meet the following criteria:
To be eligible for the study, a parent must meet the following criteria:
The presence of any of the following is an exclusion for the study:
Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving.
Behavioral: Developmental Demands
Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.
Behavioral: Distress Reduction
Optimize the use of remote monitoring by focusing on situational demands and problem solving.
Behavioral: Remote Monitoring
Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.
Behavioral: Fear of Hypoglycemia
Serves as the control group comparator. No intervention provided.
Behavioral: No intervention
Education and training related to use of CGM in this age group
Education and training on reducing distress
Education and training on the use of remote monitoring
Education and training on reducing fear of hypoglycemia
No intervention - serves as the control group
Time spent in blood glucose range
Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads.
Time frame: Change over 6 months
Pediatric Quality of Life Inventory
This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living.
Time frame: Change over 6 months
A1c
The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes. Collected through a blood sample.
Time frame: Change over 6 months
Problem Areas in Diabetes
This measure captures areas that are reported as problems for people with diabetes. Participants in the study report on daily problems with diabetes via this measure.
Time frame: Change over 6 months
Diabetes Distress Scale
This measure is widely used to capture the psychological distress experienced in relation to diabetes.
Time frame: Change over 6 months
Patient Health Questionnaire 9
This is a widely used measure that captures depressive symptoms. It is reported by the participants.
Time frame: Change over 6 months
State-Trait Anxiety Inventory
This is a widely used measure of anxiety symptoms. It is reported by the participant.
Time frame: Change over 6 months
Pittsburgh Sleep Quality Index
This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.
Time frame: Change over 6 months
Hypoglycemic Fear Survey
People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.
Time frame: Change over 6 months
Hypoglycemic Confidence Questionnaire
Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations.
Time frame: Change over 6 months
Glucose Monitoring System Satisfaction Survey
This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.
Time frame: Change over 6 months
General and diabetes-specific technology use
This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.
Time frame: Change over 6 months
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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