Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449677
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-20
Brief Title:
Bionic Pancreas in CFRD
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
A Randomized Trial of the Insulin-only Bionic Pancreas in Cystic Fibrosis Related Diabetes
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This multi-center randomized controlled trial RCT will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas System BP versus a control group using their usual care insulin delivery method and continuous glucose monitoring CGM during a 13-week study period in individuals 14 years old with cystic fibrosis-related diabetes CFRD After 13 weeks participants will continue in a 13-week Extension Phase in which the BP group will continue to use the BP system and the Usual Care group will initiate use of the BP system
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?:
None
Is an FDA AA801 Violation?:
None