NCT07474155

Steno780G Follow-up Study

Advanced Hybrid Closed-Loop Treatment in Adults With Type 1 Diabetes Not Meeting Glycaemic Targets - The Steno780G Follow-up Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Steno Diabetes Center Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Automated insulin delivery systems, also known as closed-loop systems, have shown to improve TIR, TAR, and TBR compared with insulin pump and CGM systems that cannot automatically dose insulin. Only few studies have described long-term use of AID systems over several years. Real-world studies suggest that the beneficial effects of AID systems on glycemic outcomes are sustained over time; however, a modest increase in body weight has been observed in some users, raising concerns about the metabolic trade-offs of improved glycemia. We aim to explore wether the improvements in glycemic outcomes and treatment satisfaction achieved with AID systems remain stable over multiple years, and secondly, if long-term treatment with AID systems may be associated with an increase in body weight.

Detailed description

40 participants, who have completed the Steno780G trial, will be invited to attend a follow-up visit at Steno Diabetes Center Copenhagen between 3.5 - 4.5 years after start of AID treatment to assess the long-term effects of the MiniMed 780G system.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	780G AID pump	Long term follow-up

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-08-01
• Completion: 2026-10-01
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study