Steno780G Follow-up Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSteno Diabetes Center Copenhagen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Previous participation in the Steno780G study

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • 780G AID pump

    Device

    Long term follow-up

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Cohort of 780G users1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: