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

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    University of Colorado, Denver
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Updated on 16 February 2024
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type 1 diabetes mellitus
diabetes
insulin

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.

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.

Details
Condition Diabetes Mellitus, diabetes (pediatric), Insulin dependent diabetes mellitus, diabetes (pediatric)
Age 2years - 17years
Clinical Study IdentifierNCT04431947
SponsorUniversity of Colorado, Denver
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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