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

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ClinicalTrials.gov Identifier: NCT04431947
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

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 evaluate sleep in these participants.

Condition or disease
Type 1 Diabetes

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 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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep and Psychosocial Outcomes After Initiation of Advanced Hybrid Closed-Loop Insulin Delivery Systems in Youth With Type 1 Diabetes and Their Parents
Actual Study Start Date : March 13, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort
Youth
Youth, between the ages of 2 and 17, with type 1 diabetes
Parent
Parents of youth with type 1 diabetes



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Youth with type 1 diabetes and a parent who resides with the youth.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431947


Contacts
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Contact: Emily Jost 303-724-7313 Emily.Jost@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado, Barbara Davis Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Emily Jost    303-724-7313    emily.jost@cuanschutz.edu   
Principal Investigator: Erin Cobry, MD         
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Erin Cobry, MD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04431947    
Other Study ID Numbers: 20-0375
K12DK094712 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases