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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 1 Diabetes

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Youth<br>Youth, between the ages of 2 and 17, with type 1 diabetes | |
| Parent<br>Parents of youth with type 1 diabetes | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on Diabetes Distress | Change in diabetes-related distress using the validated Problem Areas in Diabetes survey | End of study (6 months) | 
| 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) | 
| Impact on Fear of Hypoglycemia | Change in fear of hypoglycemia using the validated hypoglycemia fear survey | End of study (6 months) | 
| Impact on Perceptions of Diabetes Technology | Change in diabetes technology perceptions using the validated survey Diabetes Technology Questionnaire | End of study (6 months) | 
| 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) | 
| 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) |