This study will examine the impact of a closed-loop insulin delivery system intervention on health and psychological outcomes in families with young children with Type 1 Diabetes (T1D).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
26
Education and training related to use of CGM in this age group
Education and training on reducing distress
Education and training on how to use the HCL system to dose for different kinds of foods to improve glycemic control
Stanford University School of Medicine
Palo Alto, California, United States
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 3 months
Hemoglobin 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 3 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 3 months
Parent Diabetes Distress Scale
This measure is widely used to capture the psychological distress experienced in relation to diabetes.
Time frame: Change over 3 months
Patient Health Questionnaire 8
This is a widely used measure that captures depressive symptoms. It is reported by the participants.
Time frame: Change over 3 months
State-Trait Anxiety Inventory
This is a widely used measure of anxiety symptoms. It is reported by the participant.
Time frame: Change over 3 months
Pittsburgh Sleep Quality Index
This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.
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Education and training on reducing worries of hypoglycemia
Minimal intervention to simulate standard care - serves as the control group
Time frame: Change over 3 months
Hypoglycemic Fear Survey - Parents
People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.
Time frame: Change over 3 months
Hypoglycemia 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 3 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 3 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 3 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 3 months
Diabetes management behaviors
Amount of time spent in Auto Mode; blood glucose monitoring frequency (by meter download); adherence to pump boluses. It is objectively reported by device downloads.
Time frame: Change over 3 months
Health care utilization
Number of visits and calls to the diabetes care team.
Time frame: Change over 3 months