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

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT04431947
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2020-03-13
• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Status Verified: 2022-04
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of Sleep	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

Name	Time	Method
Impact on Quality of Life	End of study (6 months)	Change in quality of life using the validated survey Pediatric Quality of Life Inventory Diabetes Module (PedsQL)
Impact on Fear of Hypoglycemia	End of study (6 months)	Change in fear of hypoglycemia using the validated hypoglycemia fear survey
Impact on Diabetes Distress	End of study (6 months)	Change in diabetes-related distress using the validated Problem Areas in Diabetes survey
Impact on Hybrid Closed-Loop System Use Perceptions	End of study (6 months)	Change in perceptions of hybrid-closed loop systems using the validated INSPIRE survey
Impact of Sleep on Glycemic Variability	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
Impact on Perceptions of Diabetes Technology	End of study (6 months)	Change in diabetes technology perceptions using the validated survey Diabetes Technology Questionnaire

Trial Locations

Locations (1)

University of Colorado, Barbara Davis Center; 🇺🇸 Aurora, Colorado, United States