Type 1 DiabetesNCT07474155
Steno780G Follow-up Study
An observational study of Type 1 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- 780G AID pump
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2026to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants who have previously participated in the Steno780G study will be invited for a follow-up visit
Who may be able to join
- Previous participation in the Steno780G study
Who cannot join
- Lack of compliance with key study procedures at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Steno Diabetes Center Copenhagen
Herlev, 2730
Merete Christensen, MD, PhD, +45 29429113, merete.bechmann.christensen@regionh.dk
Merete Christensen, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- 780G AID pump
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
780G AID pumpDevice
Long term follow-up
| Study group | Role | What they receive |
|---|---|---|
| Cohort of 780G users | Cohort of 780G users who previously participated in the Steno780G trial Receives: Device: 780G AID pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
Measured: Last 2 weeks compared with 2 weeks before 780G start
Secondary outcomes (8)
Time above and below range
Measured: Last 2 weeks compared with 2 weeks before 780G start
HbA1c
Measured: Compared with HbA1c before 780G
Body weight
Measured: Compared with bodyweight before 780G start
Mean sensor glucose
Measured: Last 2 weeks compared with 2 weeks before 780G start
Glycemic variability
Measured: last 2 weeks compared with 2 weeks before 780G start
Diabetes treatment satisfaction score
Measured: compared with DTQS before 780G start
Hypoglycaemia Fear Survey scores
Measured: Compared with before 780G start
Diabetes Distress Scale scores
Measured: compared with before 780G start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474155
- Sponsor's protocol ID
- Steno780G-Followup
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Might be available on request
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Hybrid Closed-Loop Treatment in Adults With Type 1 Diabetes Not Meeting Glycaemic Targets - The Steno780G Follow-up Study
- ClinicalTrials.gov ID
- NCT07474155
- Acronym / sponsor ID
- Steno780G-Followup
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of 780G users | – | Device: 780G AID pumpCohort of 780G users who previously participated in the Steno780G trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants who have previously participated in the Steno780G study will be invited for a follow-up visit
Key inclusion criteria (1 listed)
- Previous participation in the Steno780G study
Key exclusion criteria (1 listed)
- Lack of compliance with key study procedures at the discretion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 780G AID pumpLong term follow-up | Device | Cohort of 780G users |
Primary outcome
Time in range
Time frame: Last 2 weeks compared with 2 weeks before 780G start
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Undecided. Might be available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merete Christensen, MD, PhD (+45 29429113, merete.bechmann.christensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: Last 2 weeks compared with 2 weeks before 780G start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.