Menu
Not yet recruiting NCT07474155

Steno780G Follow-up Study

— Observational Type 1 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 780G AID pump.
Who it may be relevant to
Registry conditions: Type 1 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device 780G AID pump
    Long term follow-up

Primary outcome measures

  • Time in range [Time frame: Last 2 weeks compared with 2 weeks before 780G start]
Secondary outcome measures (8)
  • Time above and below range [Time frame: Last 2 weeks compared with 2 weeks before 780G start]
  • HbA1c [Time frame: Compared with HbA1c before 780G]
  • Body weight [Time frame: Compared with bodyweight before 780G start]
  • Mean sensor glucose [Time frame: Last 2 weeks compared with 2 weeks before 780G start]
  • Glycemic variability [Time frame: last 2 weeks compared with 2 weeks before 780G start]
  • Diabetes treatment satisfaction score [Time frame: compared with DTQS before 780G start]
  • Hypoglycaemia Fear Survey scores [Time frame: Compared with before 780G start]
  • Diabetes Distress Scale scores [Time frame: compared with before 780G start]

Eligibility criteria

Inclusion criteria

  • Previous participation in the Steno780G study

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Steno Diabetes Center Copenhagen — Herlev

Identifiers

NCT: NCT07474155 · Steno780G-Followup

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗