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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04431947
• Other study ID #: 20-0375
• Secondary ID: K12DK094712
• Status: Completed
• Start date: March 13, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
United States	University of Colorado, Barbara Davis Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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