NCT07039617

A Randomized Parallel Clinical Trial of AIDANET, an Automated Insulin Delivery Algorithm, in Fully Closed-Loop Vs Hybrid Closed-Loop Mode In Adults With Type 1 Diabetes (AIDANET At Home)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sue Brown · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized cross-over trial assessing glycemic control on Automated insulin delivery as Adaptive Network (AIDANET) algorithm when used in three modes: AIDANET-Fully Closed Loop (FCL), AIDANET-Hybrid Closed Loop (HCL) and AIDANET allowing a mix between FCL and HCL. There will be an Automated Insulin Delivery (AID) phase with participants using their home devices and/or study continuous glucose monitor (CGM) and study-provided commercial Mobi system without AIDANET.

Detailed description

This study is a randomized cross-over trial comparing AIDANET used in three different modalities to currently available AID systems (usual care). For two 4-week phases the participants will first use the system in predetermined modality (HCL or FCL) in random order. The AIDANET system is designed to work both in full closed loop (no meal information) and in hybrid closed-loop, with carbohydrate announcement (standard bolus calculator) or easy bolus (announce timing but not carbohydrate amount), as requested by the user. During a third 4-week long phase, all participants will continue to use the system as befits their preferences (no modality will be imposed, and the user is free to go back and forth between modalities). In addition, the participant will spend 4 weeks using a usual care AID system either before the first AIDANET phase (randomization Group A) or after the last AIDANET phase (randomization Group B).

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	AIDANET + FCL	All participants will use AIDANET in fully closed loop (FCL) mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.
DEVICE	AIDANET + HCL	All participants will use AIDANET in hybrid closed loop (HCL) mode with instructions to announce all meal boluses using carbohydrate counting or easy bolus during the four weeks. All components of AIDANET will remain active during this phase but BPS in particular is expected to be triggered less often due to meal announcements.
DEVICE	AIDANET in FCL-HCL-mixed mode	All participants will use AIDANET with instructions to choose whether to use fully closed loop (FCL) or hybrid closed loop (HCL) mode with meal announcements (carb counting or easy bolus) per their discretion each day.
OTHER	Automated Insulin Delivery (AID) (usual care)	Participants will manage their diabetes as they normally do at home.

Timeline

• Start date: 2025-09-02
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2025-06-26
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study