Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347783
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-29
Brief Title:
Automated Insulin Delivery vs Injections Sleep Impact in Pediatric Type 1 Diabetes
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
The Effect of Automated Insulin Delivery on Sleep Compared to Multiple Daily Injections in Pediatric Patients With Type 1 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None