NCT06347783

Automated Insulin Delivery vs. Injections: Sleep Impact in Pediatric Type 1 Diabetes

The Effect of Automated Insulin Delivery on Sleep Compared to Multiple Daily Injections in Pediatric Patients With Type 1 Diabetes

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. We are hoping to find out if insulin pumps improve sleep, worsen sleep, or have no effect at all. We are hoping to also explore the relationship between insulin pumps, sleep, and overnight blood sugar control. Your information will not be stored and used for future research. The goal of this observational study is learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. The main questions it aims to answer are: Do insulin pumps improve sleep, worsen sleep or have no effect at all? What is the relationship between insulin pumps, sleep, and overnight blood sugar control? Participants will be asked to: * Complete questionnaires regarding demographic data and diabetes history. * Complete surveys regarding sleep quality before and after starting an insulin pump. * Wear a FitBit during sleep for 2 weeks and fill out daily sleep diaries over a 2 week period prior to starting an insulin pump. After 1-2 months after initiation of an insulin pump, participants will be asked again to: * Complete surveys regarding sleep quality * Wear a FitBit during sleep for 2 weeks * Fill out daily sleep diaries over the same 2 week period.

Conditions

• Type1diabetes

Interventions

Type	Name	Description
DEVICE	Insulin pump	Continuous subcutaneous insulin therapy.

Timeline

• Start date: 2024-05-15
• Primary completion: 2024-11-15
• Completion: 2024-12-15
• First posted: 2024-04-04
• Last updated: 2024-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study