Type 1 Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Inclusion criteria
* Child diagnosed with type 1 diabetes for at least 3 months * Child receives clinical care at the Barbara Davis Center for Diabetes * Child starting an advanced HCL system as part of routine diabetes care * Child currently living with a parent who is willing to complete surveys for this study * Family able to read and speak English * Parent lives at home with the child with type 1 diabetes * Parent able to read and speak English
Exclusion criteria
* Child has an active underlying sleep disorder, such as narcolepsy, insomnia or untreated sleep apnea * Child participating in an interventional research protocol * Child unable to complete study procedures * Parent has an active underlying sleep disorder, such as narcolepsy, insomnia or untreated sleep apnea * Parent unable to complete study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Sleep | End of study (6 months) | Change in duration of sleep before and after starting the advanced hybrid closed-loop system using surveys and activity watches |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact on Quality of Life | End of study (6 months) | Change in quality of life using the validated survey Pediatric Quality of Life Inventory Diabetes Module (PedsQL) |
| Impact on Fear of Hypoglycemia | End of study (6 months) | Change in fear of hypoglycemia using the validated hypoglycemia fear survey |
| Impact on Diabetes Distress | End of study (6 months) | Change in diabetes-related distress using the validated Problem Areas in Diabetes survey |
| Impact on Hybrid Closed-Loop System Use Perceptions | End of study (6 months) | Change in perceptions of hybrid-closed loop systems using the validated INSPIRE survey |
| Impact of Sleep on Glycemic Variability | End of study (6 months) | 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 |
| Impact on Perceptions of Diabetes Technology | End of study (6 months) | Change in diabetes technology perceptions using the validated survey Diabetes Technology Questionnaire |
Countries
United States
Outcome results
None listed