Status:

COMPLETED

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

Lead Sponsor:

University of Colorado, Denver

Collaborating Sponsors:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

Type 1 Diabetes

Eligibility:

All Genders

2-17 years

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 ...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 13 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2022

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT04431947

Start Date

March 13 2020

End Date

April 1 2022

Last Update

April 25 2022

Active Locations (1)

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University of Colorado, Barbara Davis Center

Aurora, Colorado, United States, 80045