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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort of 780G users | Cohort of 780G users who previously participated in the Steno780G trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 780G AID pump | Device | Long term follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in range | Last 2 weeks compared with 2 weeks before 780G start |
| Measure | Description | Time Frame |
|---|---|---|
| Time above and below range | Last 2 weeks compared with 2 weeks before 780G start | |
| HbA1c | Compared with HbA1c before 780G | |
| Body weight |
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Inclusion Criteria:
Exclusion Criteria:
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Study participants who have previously participated in the Steno780G study will be invited for a follow-up visit
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merete Christensen, MD, PhD | Contact | +45 29429113 | merete.bechmann.christensen@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Herlev | 2730 | Denmark |
Might be available on request
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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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| Compared with bodyweight before 780G start |
| Mean sensor glucose | Last 2 weeks compared with 2 weeks before 780G start |
| Glycemic variability | last 2 weeks compared with 2 weeks before 780G start |
| Diabetes treatment satisfaction score | compared with DTQS before 780G start |
| Hypoglycaemia Fear Survey scores | Compared with before 780G start |
| Diabetes Distress Scale scores | compared with before 780G start |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |