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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 780G-780G | Experimental | Participants will use MiniMed 780G system for 14 weeks + 14 weeks |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimed 780G insulin pump | Device | 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. |
| 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 |
| 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)): |
| Measure | Description | Time Frame |
|---|---|---|
| Number of daily carbohydrate entries in the insulin pump assessed by 2-week insulin pump data downloads | assessed by 2-week insulin pump data downloads | From baseline to week 14 |
| Hypoglycaemia awareness status. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Gentofte Municipality | 2820 | Denmark |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 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 |
Assesed by GOLD and Pedersen-Bjerggaard scale, low scores means aware, high scores means unawareness
| From baseline to week 14 |
| Diabetes Treatment Satisfaction Questionnaire scores | Assessed by Diabetes Treatment Satisfaction Questionnaire. Scores from -36 to 36, high scores means higher satisfaction | From baseline to week 14 |
| Hypoglycaemia Fear Survey scores | Assessed by Hypoglycemia Fear Survey questionnaire. Scores from 0 to 52, higher scores indicate worse outcome | From baseline to week 14 |
| Diabetes Distress Scale scores | Assessed by Diabetes Distress Scale questionnaire. DDS consists of 17 items on a 6-point scale. A score of ≥3 indicates a high diabetes distress and a score lower than 3 and ≥2 indicates a moderate diabetes distress. | From baseline to week 14 |
| Pittsburgh Sleep Quality Index scores | Assessed by PTQI questionnaire | From baseline to week 14 |
| Sleep efficiency (%) assessed by Actigraph GT3x | assessed by Actigraph GT3x | From baseline to week 14 |
| Physical activity level (sedentary, light, moderate-to-vigorous) assessed by Actigraph GT3x | assessed by Actigraph GT3x | From baseline to week 14 |
| Difference in number of severe hypoglycaemia events (cognitive impairment requiring external assistance for recovery). | Assessed by questionnaire | From baseline to week 14 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |