Steno780G Follow-up Study

NCT07474155 | Not Yet Recruiting FDA Device

• 1 other identifier: Steno780G-Followup
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Time in range

  Last 2 weeks compared with 2 weeks before 780G start

Secondary Outcomes (8)

• Time above and below range

  Last 2 weeks compared with 2 weeks before 780G start

• HbA1c

  Compared with HbA1c before 780G

• Body weight

  Compared with bodyweight before 780G start

• Mean sensor glucose

  Last 2 weeks compared with 2 weeks before 780G start

• Glycemic variability

  last 2 weeks compared with 2 weeks before 780G start

Study Arms (1)

Cohort of 780G users

Cohort of 780G users who previously participated in the Steno780G trial

Device: 780G AID pump

Interventions

780G AID pump DEVICE

Long term follow-up

Cohort of 780G users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants who have previously participated in the Steno780G study will be invited for a follow-up visit

You may qualify if:

• Previous participation in the Steno780G study

You may not qualify if:

• Lack of compliance with key study procedures at the discretion of the investigator.

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Merete Christensen, MD, PhD

CONTACT

+45 29429113; merete.bechmann.christensen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

DK (1)