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

N/ACompletedNCT04431947

University of Colorado, Denver46 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 1 Diabetes

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Colorado, Barbara Davis Center

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Duration of Sleep

Change in duration of sleep before and after starting the advanced hybrid closed-loop system using surveys and activity watches