The Steno 780G Study

Study Overview
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Brief Summary
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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.

Official Title
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Advanced Hybrid Closed-Loop Treatment in Adults With Type 1 Diabetes Not Meeting Glycaemic Targets: A Randomised Controlled Trial - The Steno 780G Study

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Minimed 780G insulin pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 780G-780G<br>Participants will use MiniMed 780G system for 14 weeks + 14 weeks | Device: Minimed 780G insulin pump<br>* 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.<br>|
| Placebo Comparator: Usual Care - 780G<br>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. | Device: Minimed 780G insulin pump<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)). | From baseline to week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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)): | 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)): | 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)): | 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)): | 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)): | 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 | 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)) | From baseline to week 14 | 
| Glucose management indicator (an estimate of the laboratory HbA1c value). | From insulin pump data downloads | From baseline to week 14 | 
| HbA1c |  | From baseline to week 14 | 
| Body weight |  | From baseline to week 14 | 
| Total daily insulin dose | Total daily insulin dose assessed by 2-week insulin pump data downloads | From baseline to week 14 | 
| Total daily carbohydrate intake | Total daily carbohydrate intake assessed by 2-week insulin pump data downloads. | From baseline to week 14 |