Steno780G Follow-up Study

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: 780G AID pump

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Merete Christensen, MD, PhD; Phone Number: +45 29429113; Email: merete.bechmann.christensen@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Steno Diabetes Center Copenhagen
    • Contact: Merete Christensen, MD, PhD; Phone Number: +45 29429113; Email: merete.bechmann.christensen@regionh.dk
    • Principal Investigator: Merete Christensen, MD, PhD
    • Sub-Investigator: Kirsten Norgaard, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• Previous participation in the Steno780G study

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort of 780G users; Cohort of 780G users who previously participated in the Steno780G trial	Device: 780G AID pump; Long term follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time in range	Last 2 weeks compared with 2 weeks before 780G start

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Diabetes treatment satisfaction score	compared with DTQS before 780G start
Hypoglycaemia Fear Survey scores	Compared with before 780G start
Diabetes Distress Scale scores	compared with before 780G start

Collaborators and Investigators

• Sponsor: Steno Diabetes Center Copenhagen

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Steno780G-Followup

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Might be available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No