NCT07020936

AIDANET Pediatrics

Safety and Feasibility Testing of AIDANET in Children Age 6-13 Years

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Mark D. DeBoer, MD, MSc., MCR · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

AIDANET algorithm with smart-phone based control system (study smart phone), specifically modified Tandem insulin system (study insulin pump), and Dexcom G6 CGM (study CGM).

Detailed description

This study aims to demonstrate the safety and feasibility of the Automated insulin delivery as Adaptive NETwork (AIDANET) system among children age 6-13 years. This includes use of new features allowing requested correction boluses and setting a tighter glycemia goal. The proposed work is a safety and feasibility study of the FCL system and is not intended to be powered to fully demonstrate efficacy of the system. The sample size of up to 24 completed participants was selected based on previous experience of the feasible number of individuals to supervise at one time under similar study conditions.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Normal Glycemia Goal	Participants will use the normal AIDANET system aggressivity adjustment to achieve target glucose for both the hotel and AIDANET at home periods.
DEVICE	Tight Glycemia Goal	Participants will have the AIDANET system controller target set to have higher aggressivity adjustment to maintain target glucose for both the hotel and AIDANET at home periods.

Timeline

• Start date: 2025-07-21
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2025-06-13
• Last updated: 2025-12-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study