Developmental Demands
BehavioralEducation and training related to use of CGM in this age group
NCT Number: NCT02848261
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).
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Notify Me2 year–6 year
All sexes
Interventional
Not applicable
Stanford University, Stanford, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
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 frame: Change over 6 months
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
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
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
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
This measure is widely used to capture the psychological distress experienced in relation to diabetes.
Time frame: Change over 6 months
This is a widely used measure that captures depressive symptoms. It is reported by the participants.
Time frame: Change over 6 months
This is a widely used measure of anxiety symptoms. It is reported by the participant.
Time frame: Change over 6 months
This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.
Time frame: Change over 6 months
People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants.
Time frame: Change over 6 months
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
This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.
Time frame: Change over 6 months
This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.
Stanford University
Other
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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.
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