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This is a staggered randomised controlled trial that aims to assess the impact of an automated insulin delivery (AID) system on glucose, gastrointestinal and patient-reported outcomes.
Following a run-in period of 2 weeks, participants will be randomised to control or hybrid automated insulin delivery (AID) using the 780G system and will remain in the intervention phase of the study for 12 weeks (4-week control, then 4-week AID or Control and finally 4-week AID). The total duration for each participant will be 14 weeks. There are 5 study visits (combination of face to face or/and remote) and two telephone visits in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid Automated Insulin Delivery | Experimental | The intervention is the Medtronic 780G Hybrid Automated Insulin Delivery system |
|
| Standard care | No Intervention | The control is Standard Care with real-time CGM |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Automated Insulin Delivery | Device | Consists of an insulin pump and real-time continuous glucose monitoring (CGM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage time spent in glucose target (3.9-10mmol/L) | The change in percentage time in glucose target between baseline and intervention/control | 4 - 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage time spent in hypoglycaemia (<3.0mmol/L) | The change in percentage time in hypoglycaemia(<3.0mmol/L) between baseline and intervention/control | 4 - 8 weeks |
| Percentage time spent in hypoglycaemia (<3.9mmol/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monika Reddy, PhD | Contact | +44 (0)20 7594 1796 | m.reddy@imperial.ac.uk | |
| Nick Oliver, FRCP | Contact | +44 (0)20 7594 1796 | nick.oliver@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Nick Oliver | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London and Imperial College Healthcare NHS Trust | Recruiting | London | W12 0HS | United Kingdom |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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Staggered randomised control trial
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The change in percentage time in hypoglycaemia (<3.9mmol/L) between baseline and intervention/control
| 4 - 8 weeks |
| Percentage time spent in hyperglycaemia (>10mmol/L) | The change in percentage time in hyperglycaemia (>10mmol/L) between baseline and intervention/control | 4 - 8 weeks |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |