NCT06633965

Safety and Feasibility Testing of a Smaller Network Version of AIDANET

Safety and Feasibility Testing of a Smaller Network Version of AIDANET (MiniNET)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Marc Breton · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A randomized 1:1 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 hotel. Following the hotel session, participants will undergo a 7 day/6-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 1:1, to either Group A (control period prior to AIDANET use) or Group B (control period after AIDANET use).

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	AIDANET	AIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions.
DEVICE	AIDANET	AIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions.

Timeline

• Start date: 2024-11-20
• Primary completion: 2024-12-16
• Completion: 2024-12-18
• First posted: 2024-10-09
• Last updated: 2025-08-14
• Results posted: 2025-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study