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NCT Number: NCT07474155

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location contact

Kirsten Norgaard, Professor

SUB_INVESTIGATOR

Merete Christensen, MD, PhD

CONTACT

[email protected]

+45 29429113

Merete Christensen, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previous participation in the Steno780G study

Exclusion criteria

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

Treatment and study plan

780G AID pump

Device

Long term follow-up

Primary outcomes

  1. Time in range

    Time frame: Last 2 weeks compared with 2 weeks before 780G start

Secondary outcomes

  1. Time above and below range

    Time frame: Last 2 weeks compared with 2 weeks before 780G start

  2. HbA1c

    Time frame: Compared with HbA1c before 780G

  3. Body weight

    Time frame: Compared with bodyweight before 780G start

  4. Mean sensor glucose

    Time frame: Last 2 weeks compared with 2 weeks before 780G start

  5. Glycemic variability

    Time frame: last 2 weeks compared with 2 weeks before 780G start

  6. Diabetes treatment satisfaction score

    Time frame: compared with DTQS before 780G start

  7. Hypoglycaemia Fear Survey scores

    Time frame: Compared with before 780G start

  8. Diabetes Distress Scale scores

    Time frame: compared with before 780G start

Study contacts

Contact information is provided by the study sponsor or research team.

Merete Christensen, MD, PhD

CONTACT

[email protected]

+45 29429113

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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