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

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

Recruiting
2-17 years
All
Phase N/A

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.

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

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

Study details
    Diabetes Mellitus
    diabetes (pediatric)
    Insulin dependent diabetes mellitus
    diabetes (pediatric)

NCT04431947

University of Colorado, Denver

16 February 2024

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