Type 1 DiabetesNCT04914910
The Steno 780G Study
A study testing Minimed 780G insulin pump in people with Type 1 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
Treatment with insulin pumps and sensor-based glucose monitoring has proven superior to other treatment methods in type 1 diabetes. Still, the majority of people treated with insulin pumps and glucose sensors still does not meet the recommended sensor-based glycaemic targets. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Minimed 780G insulin pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Jun 2021to 29 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Type 1 diabetes ≥2 years.
- HbA1c >=58 mmol/mol
- Insulin pump treatment ≥12 months
- CGM or isCGM use ≥6 months
- Novorapid use ≥1 week
- Carbohydrate counting and use of the insulin pump bolus calculator for most snacks and meals.
- Carbohydrate intake >80 grams per day (assessed by review of intake recorded in the insulin pump during the 2 weeks prior to the screening visit)
Who cannot join
- Breast-feeding, pregnancy or planning to become pregnant.
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start.
- Use of hybrid closed-loop systems
- Daily use of paracetamol (acetaminophen)
- Alcohol or drug abuse.
- Severe cardiac disease or retinopathy contraindicating HbA1c <53 mmol/mol.
Show all 9Show fewer
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the person unsuitable for study participation.
- Lack of compliance with key study procedures at the discretion of the investigator.
- Unacceptable adverse events at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advanced Hybrid Closed-Loop Treatment in Adults With Type 1 Diabetes Not Meeting Glycaemic Targets: A Randomised Controlled Trial - The Steno 780G Study
Treatment with insulin pumps and sensor-based glucose monitoring has proven superior to other treatment methods in type 1 diabetes. Still, the majority of people treated with insulin pumps and glucose sensors still does not meet the recommended sensor-based glycaemic targets. 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.
The primary objective of the Steno 780G study is to test the effects of the MiniMed 780G system in persons with T1D treated with insulin pump and CGM/isCGM who are not meeting glycaemic targets.
- Conditions
- Type 1 Diabetes
- Being tested
- Minimed 780G insulin 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.
Minimed 780G insulin pumpDevice
This will be a 14-week, open-label, randomised, parallel-group, controlled trial comparing the efficacy of an AHCL system (MiniMed 780G, Medtronic Diabetes, Northridge, CA) with usual care (i.e., a person's usual insulin pump and CGM/isCGM system). After the 14-week trial period, the control group switches to treatment with the MiniMed 780G system. The intervention group continues with the MiniMed 780G system. Both groups are monitored for another 14 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 780G-780G | Experimental | Participants will use MiniMed 780G system for 14 weeks + 14 weeks Receives: Device: Minimed 780G insulin pump |
| Usual Care - 780G | Placebo comparator | Participants will continue with their usual insulin pump for 14 weeks. After completion of the first 14-week periode, they switch to 780G for another 14 weeks. Receives: Device: Minimed 780G insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14
Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14 assessed by 2 weeks of CGM data (12 AM-12 AM (wake + sleep)).
Measured: From baseline to week 14
Secondary outcomes (13)
Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14 assessed by 2-week CGM data (6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep))
Measured: From baseline to week 14
Difference in mean glucose
difference in change in the given variable between treatment groups from baseline to Week 14 assessed by 2 weeks of CGM data (each of the endpoints will be calculated for the following 3-time intervals: 6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep), 12 AM - 12AM (wake + sleep)):
Measured: From baseline to week 14
Difference in standard deviation
difference in change in the given variable between treatment groups from baseline to Week 14 assessed by 2 weeks of CGM data (each of the endpoints will be calculated for the following 3-time intervals: 6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep), 12 AM - 12AM (wake + sleep)):
Measured: From baseline to week 14
Difference in coefficient of variation
difference in change in the given variable between treatment groups from baseline to Week 14 assessed by 2 weeks of CGM data (each of the endpoints will be calculated for the following 3-time intervals: 6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep), 12 AM - 12AM (wake + sleep)):
Measured: From baseline to week 14
Percentage of time with glucose values < 3.9 mmol/l (TBR level 1).
difference in change in the given variable between treatment groups from baseline to Week 14 assessed by 2 weeks of CGM data (each of the endpoints will be calculated for the following 3-time intervals: 6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep), 12 AM - 12AM (wake + sleep)):
Measured: From baseline to week 14
Percentage of time with glucose values < 3.0 mmol/l (TBR level 2).
difference in change in the given variable between treatment groups from baseline to Week 14 assessed by 2 weeks of CGM data (each of the endpoints will be calculated for the following 3-time intervals: 6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep), 12 AM - 12AM (wake + sleep)):
Measured: From baseline to week 14
Percentage of time with glucose values > 10.0 mmol/l (TAR level 1).
difference in change in the given variable between treatment groups from baseline to
Measured: From baseline to week 14
Percentage of time with glucose values > 13.9 mmol/l (TAR level 2).
difference in change in the given variable between treatment groups from baseline to Week 14 assessed by 2 weeks of CGM data (each of the endpoints will be calculated for the following 3-time intervals: 6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep), 12 AM - 12AM (wake + sleep))
Measured: From baseline to week 14
Glucose management indicator (an estimate of the laboratory HbA1c value).
From insulin pump data downloads
Measured: From baseline to week 14
HbA1c
Measured: From baseline to week 14
Body weight
Measured: From baseline to week 14
Total daily insulin dose
Total daily insulin dose assessed by 2-week insulin pump data downloads
Measured: From baseline to week 14
Total daily carbohydrate intake
Total daily carbohydrate intake assessed by 2-week insulin pump data downloads.
Measured: From baseline to week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start8 Jun 2021
- Primary completion15 Dec 2022
- Study completion29 Mar 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merete Bechmann Christensen, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914910
- Sponsor's protocol ID
- Steno 780G
- Status last verified
- Sep 2023
- First submitted
- 31 May 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. 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: A Randomised Controlled Trial - The Steno 780G Study
- ClinicalTrials.gov ID
- NCT04914910
- Acronym / sponsor ID
- Steno 780G
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 7 Jun 2021 (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.
Treatment with insulin pumps and sensor-based glucose monitoring has proven superior to other treatment methods in type 1 diabetes. Still, the majority of people treated with insulin pumps and glucose sensors still does not meet the recommended sensor-based glycaemic targets. 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.
The primary objective of the Steno 780G study is to test the effects of the MiniMed 780G system in persons with T1D treated with insulin pump and CGM/isCGM who are not meeting glycaemic targets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 780G-780G | Experimental | Device: Minimed 780G insulin pumpParticipants will use MiniMed 780G system for 14 weeks + 14 weeks |
| Usual Care - 780G | Placebo comparator | Device: Minimed 780G insulin pumpParticipants will continue with their usual insulin pump for 14 weeks. After completion of the first 14-week periode, they switch to 780G for another 14 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years
- Type 1 diabetes ≥2 years.
- HbA1c >=58 mmol/mol
- Insulin pump treatment ≥12 months
- CGM or isCGM use ≥6 months
Key exclusion criteria (9 listed)
- Breast-feeding, pregnancy or planning to become pregnant.
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start.
- Use of hybrid closed-loop systems
- Daily use of paracetamol (acetaminophen)
- Alcohol or drug abuse.
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 |
|---|---|---|
| Minimed 780G insulin pumpThis will be a 14-week, open-label, randomised, parallel-group, controlled trial comparing the efficacy of an AHCL system (MiniMed 780G, Medtronic Diabetes, Northridge, CA) with usual care (i.e., a person's usual insulin pump and CGM/isCGM system). After the 14-week trial period, the control group switches to treatment with the MiniMed 780G system. The intervention group continues with the MiniMed 780G system. Both groups are monitored for another 14 weeks. | Device | 780G-780G, Usual Care - 780G |
Primary outcome
Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14
Time frame: From baseline to week 14
Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14 assessed by 2 weeks of CGM data (12 AM-12 AM (wake + sleep)).
13 secondary outcomes
Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14 assessed by 2-week CGM data (6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep))
Time frame: From baseline to week 14
Difference in mean glucose
Time frame: From baseline to week 14
Difference in standard deviation
Time frame: From baseline to week 14
Difference in coefficient of variation
Time frame: From baseline to week 14
Percentage of time with glucose values < 3.9 mmol/l (TBR level 1).
Time frame: From baseline to week 14
Percentage of time with glucose values < 3.0 mmol/l (TBR level 2).
Time frame: From baseline to week 14
Percentage of time with glucose values > 10.0 mmol/l (TAR level 1).
Time frame: From baseline to week 14
Percentage of time with glucose values > 13.9 mmol/l (TAR level 2).
Time frame: From baseline to week 14
Glucose management indicator (an estimate of the laboratory HbA1c value).
Time frame: From baseline to week 14
HbA1c
Time frame: From baseline to week 14
Body weight
Time frame: From baseline to week 14
Total daily insulin dose
Time frame: From baseline to week 14
Total daily carbohydrate intake
Time frame: From baseline to week 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimed 780G insulin pump in people with 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 21 Sep 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14 (time frame: From baseline to week 14). 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 21 Sep 2023.