Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-25 @ 1:24 PM
Study NCT ID:
NCT06728059
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2024-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm
Sponsor:
Sue Brown
Organization:
Study Overview
Official Title:
Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm
Status:
RECRUITING
Status Verified Date:
2025-05
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:
AIDANET+BPS_RL
Brief Summary:
A randomized crossover trial assessing glycemic control using Reinforcement Learning trained Bolus Priming System (BPS\_RL) added to the the Automated Insulin Delivery as Adaptive NETwork (AIDANET algorithm) compared to the original AIDANET algorithm.
Detailed Description:
After receiving training on the study equipment, participants will use the AIDANET system at home for 7 days/6 nights to establish a baseline and initialize the control algorithm. Participants will then be studied at a hotel session for 3 days/2 nights. Participants will transition to home use of AIDANET+ BPS\_RL for 7 days/6 nights.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DK133148 | NIH | None | https://reporter.nih.gov/quic… | View |