The Steno 780G Study
- Conditions
- Type 1 Diabetes
- Interventions
- Device: Minimed 780G insulin pump
- Registration Number
- NCT04914910
- Lead Sponsor
- Steno Diabetes Center Copenhagen
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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)
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 780G-780G Minimed 780G insulin pump Participants will use MiniMed 780G system for 14 weeks + 14 weeks Usual Care - 780G Minimed 780G insulin pump 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.
- Primary Outcome Measures
Name Time Method Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14 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)).
- Secondary Outcome Measures
Name Time Method Difference in standard deviation From baseline to week 14 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)):
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)) From baseline to week 14 Body weight From baseline to week 14 Difference in coefficient of variation From baseline to week 14 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)):
Percentage of time with glucose values > 13.9 mmol/l (TAR level 2). From baseline to week 14 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))
Difference in mean glucose From baseline to week 14 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)):
Percentage of time with glucose values > 10.0 mmol/l (TAR level 1). From baseline to week 14 difference in change in the given variable between treatment groups from baseline to
HbA1c From baseline to week 14 Total daily insulin dose From baseline to week 14 Total daily insulin dose assessed by 2-week insulin pump data downloads
Total daily carbohydrate intake From baseline to week 14 Total daily carbohydrate intake assessed by 2-week insulin pump data downloads.
Percentage of time with glucose values < 3.9 mmol/l (TBR level 1). From baseline to week 14 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)):
Percentage of time with glucose values < 3.0 mmol/l (TBR level 2). From baseline to week 14 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)):
Glucose management indicator (an estimate of the laboratory HbA1c value). From baseline to week 14 From insulin pump data downloads
Trial Locations
- Locations (1)
Steno Diabetes Center Copenhagen
🇩🇰Gentofte, Denmark