Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654713
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Closed Loop Impact on Pregnancy Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Closed Loop Impact on Pregnancy CLIP Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLIP
Brief Summary:
The goal of this observational study is to better understand what happens when pregnant people with type 1 diabetes T1D use automated insulin delivery AID systems The main questions this study aims to answer are
What are the maternal and neonatal outcomes with AID system use in pregnancy
What are the glycemic outcomes with AID system use in pregnancy
What are the behavioral and emotional outcomes with AID system use in pregnancy
Researchers will compare pregnant people who use commercial AID systems and pregnant people who use open source AID systems to see if outcomes are different with these different types of systems
Participants will be asked to remotely share their AID system data with the research team complete online surveys regarding behavioral and emotional health and sign an authorization to release health information to allow the research team to access medical records
What are the maternal and neonatal outcomes with AID system use in pregnancy
What are the glycemic outcomes with AID system use in pregnancy
What are the behavioral and emotional outcomes with AID system use in pregnancy
Researchers will compare pregnant people who use commercial AID systems and pregnant people who use open source AID systems to see if outcomes are different with these different types of systems
Participants will be asked to remotely share their AID system data with the research team complete online surveys regarding behavioral and emotional health and sign an authorization to release health information to allow the research team to access medical records
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None