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Completed

NCT Number: NCT04431947

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado, Barbara Davis Center

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Duration of Sleep

    Time frame: End of study (6 months)

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

Secondary outcomes

  1. Impact on Diabetes Distress

    Time frame: End of study (6 months)

    Change in diabetes-related distress using the validated Problem Areas in Diabetes survey

  2. Impact on Quality of Life

    Time frame: End of study (6 months)

    Change in quality of life using the validated survey Pediatric Quality of Life Inventory Diabetes Module (PedsQL)

  3. Impact on Fear of Hypoglycemia

    Time frame: End of study (6 months)

    Change in fear of hypoglycemia using the validated hypoglycemia fear survey

  4. Impact on Perceptions of Diabetes Technology

    Time frame: End of study (6 months)

    Change in diabetes technology perceptions using the validated survey Diabetes Technology Questionnaire

  5. Impact on Hybrid Closed-Loop System Use Perceptions

    Time frame: End of study (6 months)

    Change in perceptions of hybrid-closed loop systems using the validated INSPIRE survey

  6. Impact of Sleep on Glycemic Variability

    Time frame: End of study (6 months)

    Correlation of sleep duration and glycemic variability using hybrid closed loop device download to analyze time in range, time with low glucose and time with high glucose

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

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

Registry information

Official study title

Sleep and Psychosocial Outcomes After Initiation of Advanced Hybrid Closed-Loop Insulin Delivery Systems in Youth With Type 1 Diabetes and Their Parents

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2020
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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