NCT07501338

Early Automated Insulin Delivery (AID) Pilot for Newly Diagnosed T1D

Early AID Pilot for Newly Diagnosed T1D

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 2 Years – 26 Years
• Healthy volunteers: Not accepted

Summary

Type 1 diabetes is a common chronic medical condition among youth in the US that requires intensive glycemic management to prevent long-term morbidity and mortality. Current pediatric diabetes care in the US underutilizes automated insulin delivery (AID) systems, which are the best available tools for promoting tight glycemic control while reducing user burden. This proposal aims to support early and sustained use of AID systems by examining and optimizing conditions, evaluating glycemic outcomes, and identifying contextual facilitators and barriers of implementation.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Tandem Automated Insulin Delivery System	Participants will be required to initiate AID system within 2-4 weeks of diabetes diagnosis, use a simplified meal announcement (SMA) strategy for insulin dosing. AID combines a continuous glucose monitor, an insulin pump, and a dosing algorithm to continuously adjust insulin delivery based on current and predicted future glucose levels.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2031-03-01
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study