Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633965
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Safety and Feasibility Testing of a Smaller Network Version of AIDANET
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Feasibility Testing of a Smaller Network Version of AIDANET MiniNET
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:
MiniNET
Brief Summary:
A randomized 11 crossover trial that intends to demonstrate feasibility and safety of the Automated Insulin Delivery as Adaptive NETwork AIDANET system run in a new smaller network version used in full closed loop FCL by adults who have been diagnosed with type 1 diabetes T1D
Detailed Description:
The study will be performed for about 36 hours at a local hotelrental Following the househotel session participants will undergo a 7 day6-night Remote Monitored At-Home use session A one-week control period gathering data on glycemic control and insulin administration with the participants usual care therapy will also be completed Participants will be randomized 11 to either Group A control period prior to AIDANET use or Group B control period after AIDANET use
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