Impact of Hybrid Closed-Loop Systems on Sleep and Psychosocial Outcomes in Youth With T1D and Their Parents

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Type 1 Diabetes

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04431947

K12DK094712 (U.S. NIH Grant/Contract)

20-0375

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

46 participants in 2 patient groups

Youth

Description:

Youth, between the ages of 2 and 17, with type 1 diabetes

Parent

Description:

Parents of youth with type 1 diabetes