Impact of Hybrid Closed-Loop Systems on Sleep and Psychosocial Outcomes in Youth With T1D and Their Parents
Sleep and Psychosocial Outcomes After Initiation of Advanced Hybrid Closed-Loop Insulin Delivery Systems in Youth With Type 1 Diabetes and Their Parents
2 other identifiers
observational
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 13, 2020
CompletedFirst Submitted
Initial submission to the registry
June 2, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedApril 25, 2022
April 1, 2022
2.1 years
June 2, 2020
April 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of Sleep
Change in duration of sleep before and after starting the advanced hybrid closed-loop system using surveys and activity watches
End of study (6 months)
Secondary Outcomes (6)
Impact on Diabetes Distress
End of study (6 months)
Impact on Quality of Life
End of study (6 months)
Impact on Fear of Hypoglycemia
End of study (6 months)
Impact on Perceptions of Diabetes Technology
End of study (6 months)
Impact on Hybrid Closed-Loop System Use Perceptions
End of study (6 months)
- +1 more secondary outcomes
Study Arms (2)
Youth
Youth, between the ages of 2 and 17, with type 1 diabetes
Parent
Parents of youth with type 1 diabetes
Eligibility Criteria
Youth with type 1 diabetes and a parent who resides with the youth.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado, Barbara Davis Center
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin Cobry, MD
University of Colorado, Denver
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2020
First Posted
June 16, 2020
Study Start
March 13, 2020
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
April 25, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share