Clinical trial NCT04431947: Impact of Hybrid Closed-Loop Systems on Sleep and Psychosocial Outcomes in Youth With T1D and Their Parents
Official title: Sleep and Psychosocial Outcomes After Initiation of Advanced Hybrid Closed-Loop Insulin Delivery Systems in Youth With Type 1 Diabetes and Their Parents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-06-16
Enrollment: 46
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Youth with type 1 diabetes and a parent who resides with the youth.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of Sleep
timeFrame: End of study (6 months)
Secondary outcomes:
measure: Impact on Diabetes Distress
timeFrame: End of study (6 months)
measure: Impact on Quality of Life
timeFrame: End of study (6 months)
measure: Impact on Fear of Hypoglycemia
timeFrame: End of study (6 months)
measure: Impact on Perceptions of Diabetes Technology
timeFrame: End of study (6 months)
measure: Impact on Hybrid Closed-Loop System Use Perceptions
timeFrame: End of study (6 months)
measure: Impact of Sleep on Glycemic Variability
timeFrame: End of study (6 months)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, Barbara Davis Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Erin Cobry, MD
role: PRINCIPAL_INVESTIGATOR
References: