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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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The aim of this pilot study is to generate preliminary data of (i) Fiasp-plus-Pramlintide closed-loop system with a simple meal announcement, compared to (ii) Fiasp-alone closed-loop system with full carbohydrate counting, in preparation for an outpatient study over two weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simple Meal Announcement | Experimental | Before every meal, the meal will be simply announced to the algorithm by a member of the study team. Meal bolus computation will be independent of the carbohydrate content of the meal. |
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| Full Carbohydrate counting | Active Comparator | The carbohydrate content of the meal selected by the participant will be entered into the dosing algorithm by a member of the study team at the onset of the meal to compute the insulin prandial bolus. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiasp+Pramlintide Closed-Loop System | Combination Product | Closed-loop insulin delivery with Fiasp insulin and pramlintide |
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| Measure | Description | Time Frame |
|---|---|---|
| Time in target | Time spent in target range (between 4.0 mmol/L and 10 mmol/L) | 24 hours |
| Time in hypoglycemia | Time spent in hypoglycemic range (below 4.0 mmol/L) | 24 hours |
| Time in hyperglycemia | Time spent in hyperglycemic range (above 10.0 mmol/L) | 24 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia treatment | Number of participants experiencing hypoglycemia requiring oral treatment | 24 hrs |
| Hypoglycemia treatment | Number of participants experiencing hypoglycemia requiring oral treatment |
Inclusion Criteria:
Exclusion Criteria:
Study Discontinuation/Withdrawal
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Center | Montreal | Quebec | H4A 3J1 | Canada |
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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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This study is a randomized, 2-way, crossover trial assessing:
i. Fiasp-alone closed-loop system with full carbohydrate counting ii. Fiasp-plus-Pramlintide closed-loop system with simple meal announcement in regulating glucose levels in patients with type 1 diabetes, over a period of 24h in an inpatient setting.
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| Fiasp Closed-Loop System | Device | Closed-loop insulin delivery with Fiasp insulin alone |
|
| During the night of the 24 hour intervention (11pm-7am) |
| Hypoglycemia treatment | Number of participants experiencing hypoglycemia requiring oral treatment | During the day of the 24 hour intervention (7am-11pm) |
| Gastrointestinal symptoms | Presence of gastrointestinal symptoms | 24 hours |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |