An observational study in Type 1 Diabetes, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by University of Colorado, Denver · Observational
This study evaluates the impact of the hybrid closed-loop insulin delivery systems on sleep in youth with type 1 diabetes and their parents. Activity watches, surveys and device downloads are used to evaluate sleep in these participants.
Sleep is important for everyone, including youth with type 1 diabetes. New technology has shown improvements in glycemic variability, especially overnight. This study evaluates the impact of advanced hybrid closed-loop insulin delivery systems on sleep for both youth with type 1 diabetes and their parents. Study measures include wearing an actigraphy watch and completing a sleep diary for 7 days and taking surveys on sleep and psychosocial measures. Study measures occur prior to starting the hybrid closed-loop system, immediately after starting the system and at 3 and 6 months after starting the system.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 46 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Youth with type 1 diabetes and a parent who resides with the youth.
Exclusion Criteria:
Youth, between the ages of 2 and 17, with type 1 diabetes
Parents of youth with type 1 diabetes
Duration of Sleep
Change in duration of sleep before and after starting the advanced hybrid closed-loop system using surveys and activity watches
Time frame: End of study (6 months)
Impact on Diabetes Distress
Change in diabetes-related distress using the validated Problem Areas in Diabetes survey
Time frame: End of study (6 months)
Impact on Quality of Life
Change in quality of life using the validated survey Pediatric Quality of Life Inventory Diabetes Module (PedsQL)
Time frame: End of study (6 months)
Impact on Fear of Hypoglycemia
Change in fear of hypoglycemia using the validated hypoglycemia fear survey
Time frame: End of study (6 months)
Impact on Perceptions of Diabetes Technology
Change in diabetes technology perceptions using the validated survey Diabetes Technology Questionnaire
Time frame: End of study (6 months)
Impact on Hybrid Closed-Loop System Use Perceptions
Change in perceptions of hybrid-closed loop systems using the validated INSPIRE survey
Time frame: End of study (6 months)
Impact of Sleep on Glycemic Variability
Correlation of sleep duration and glycemic variability using hybrid closed loop device download to analyze time in range, time with low glucose and time with high glucose
Time frame: End of study (6 months)
Plan to share: No
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver